IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K243036 | IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) |
Bestway Plastic And Metal Products Ltd. |
06/15/2025 | OHT |
| K242863 | Bioptimal Bipolar Pacing Catheter |
Bioptimal International Pte. Ltd. |
06/15/2025 | LDF |
| K240795 | Withings ECG App | Withings | 06/15/2025 | QDA |
| K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. |
06/13/2025 | QVF |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) |
Brainlab AG | 06/13/2025 | QIH |
| K250759 | 3 In 1 TENS UNIT | Changsha Anxiang Medical Technology Co., LTD |
06/13/2025 | NGX |
| K251485 | Excipio LV Prime Thrombectomy Device |
Contego Medical, Inc. | 06/13/2025 | QEW |
| K250251 | Eleganz Fusion Screw System (Fusion Screw System) |
Dev4 | 06/13/2025 | HWC |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) |
Fresenius Medical Care Renal Therapies Group, LLC |
06/13/2025 | KDI |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 |
FUJIFILM Corporation | 06/13/2025 | EOQ |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) |
inomed Medizintechnik GmbH |
06/13/2025 | ETN |
| K251189 | Aventus Thrombectomy System | Inquis Medical | 06/13/2025 | QEW |
| K250674 | Vessel Sealer Curved (480522) | Intuitive Surgical, Inc. | 06/13/2025 | NAY |
| K243729 | Prismira | Lumos Labs, Inc. | 06/13/2025 | QFT |
| K251166 | Mfinity Femoral System | Medacta International S.A. |
06/13/2025 | MEH |
| K250075 | Medtronic Stedi Extra Support Guidewire |
Medtronic Inc | 06/13/2025 | DQX |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) |
MicroVention | 06/13/2025 | JCX |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 06/13/2025 | ITX |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) |
Beijing Sano Laser S&T Development Co.,Ltd |
06/12/2025 | GEX |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer |
Biocomposites Ltd. | 06/12/2025 | KWL |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 Μg/ml) |
bioMérieux | 06/12/2025 | JWY |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped |
Davol Inc. | 06/12/2025 | FTL |
| K250826 | Multi M Series | DMAX Co., Ltd. | 06/12/2025 | EIH |
| K243683 | Deka Bluebeam | El.En. S.p.A. | 06/12/2025 | GEX |
| K251153 | Aurora | GE Medical Systems Israel |
06/12/2025 | KPS |
| K250559 | GMReis Fibula Nail System | GM Dos Reis Industria e Comercio |
06/12/2025 | HSB |
| K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments |
HT Medical d.b.a. Xenix Medical |
06/12/2025 | NKB |
| K242872 | Idart Lyme IgM ImmunoBlot Kit | ID-FISH Technology, Inc. | 06/12/2025 | LSR |
| K243973 | FIX-L PEEK PLIF And T-PLIF System |
Jeil Medical Corporation | 06/12/2025 | MAX |
| K251209 | Medical Monitor (32HS710S) | LG Electronics Inc. | 06/12/2025 | GCJ |
| K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft |
Medtronic Sofamor Danek, Inc. |
06/12/2025 | MQV |
| K251459 | OneLIF™ Interbody Fusion System |
NovApproach Spine, LLC | 06/12/2025 | OVD |
| K251279 | Disposable Cytology Brush BC-202D/203D Series |
Olympus Medical Systems Corporation |
06/12/2025 | BTG |
| K243234 | Second Opinion® CS | Pearl Inc. | 06/12/2025 | MYN |
| K243608 | TRIGEN Stable Lock Nut & Washer |
Smith & Nephew, Inc. | 06/12/2025 | JDS |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 Μg) AZA50 |
Thermo Fisher Scientific (Oxoid Ltd.) |
06/12/2025 | JTN |
| K250782 | Fractional CO2 Laser Machine | Zhengzhou PZ Laser Slim Technology Co., Ltd. |
06/12/2025 | GEX |
| K250269 | Ambu® Ascope™ 5 Cysto HD (Standard Deflection); Ambu® Ascope™ 5 Cysto HD (Reverse Deflection) |
Ambu A/S | 06/11/2025 | FAJ |
| K250933 | LORRAINE 2.5/3.5mm Distal Humerus System |
Bonebridge AG | 06/11/2025 | HRS |
| K250584 | Rezum System | Boston Scientific Corporation |
06/11/2025 | KNS |
| K242801 | MICOR 700 System (N/A); MICOR 700 Drive (FG-50631); MICOR 700 Extractor (FG-50621); MICOR 700 Vitrector (FG-51185) |
Carl Zeiss Meditec Cataract Technology Inc. |
06/11/2025 | HQC |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) |
Enpuno Co., Ltd | 06/11/2025 | KIF |
| K243482 | Self-Forming Magnet (Flexagon) | GI Windows Inc. | 06/11/2025 | SAH |
| K240852 | Da Vinci X Surgical System (IS4200); Da Vinci Xi Surgical System (IS4000) |
Intuitive Surgical, Inc. | 06/11/2025 | NAY |
| K250787 | Liberant Thrombectomy System | Medtronic, Ireland | 06/11/2025 | QEW |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies |
06/11/2025 | HTY |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) |
William Cook Europe Aps | 06/11/2025 | BTR |
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation | 06/10/2025 | OWB |
| K242996 | EndyMed PRO MAX | EndyMed Medical Ltd. | 06/10/2025 | GEI |
| K250735 | Dental Barrier And Sleeves | Fomed Industries, Inc. | 06/10/2025 | PEM |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP |
FUJIFILM Corporation | 06/10/2025 | FDS |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) |
Nihon Kohden Corporation | 06/10/2025 | CCK |
| K250768 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 06/10/2025 | QVP |
| K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, Sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, Sizes 6.0-10.0mm |
Vitaltec Corporation | 06/10/2025 | BTO |
| K250354 | Viz Subdural+, Viz SUBDURAL PLUS |
Viz.ai, Inc. | 06/10/2025 | QIH |
| K251500 | MallyaG Injection Pen Adapter (MallyaG) |
Biocorp Production | 06/09/2025 | QOG |
| K250465 | CO2 Laser Machine (Lume) | Nanjing Bestview Laser S&T Co., Ltd. |
06/09/2025 | GEX |
| K251093 | Bonvadis® | Oneness Biotech Co., Ltd. |
06/09/2025 | FRO |
| K250830 | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) |
Shenzhen Sungrow LED Technology Co., Ltd. |
06/09/2025 | OHS |
| K250746 | Magnetic Surgical System | Levita Magnetics International Corp. |
06/07/2025 | PNL |
| K242907 | DELPHI System | CnS Medical Co., Ltd. | 06/06/2025 | GEI |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C |
ConvaTec Limited | 06/06/2025 | FCM |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) |
Creo Medical Ltd | 06/06/2025 | KNS |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal |
Empatica S.r.l. | 06/06/2025 | MWI |
| K242759 | Geister K-Rex Rongeurs | Geister Medizin Technik GmbH |
06/06/2025 | HAE |
| K250321 | GCI Sterilization Wrappers | George Courey Inc. | 06/06/2025 | FRG |
| K243456 | ONVOY™ Acetabular System | Globus Medical, Inc | 06/06/2025 | LPH |
| K251042 | Light Therapy System (M500, L6) |
Guangzhou Ahead Intelligent Technology Co., Ltd. |
06/06/2025 | OHS |
| K250722 | Nd: YAG Laser Therapy System (QN-1) |
Hebei JT Medical Co., Ltd. |
06/06/2025 | GEX |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) |
KARL STORZ SE & CO. KG | 06/06/2025 | FGB |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay |
Luminex Corporation | 06/06/2025 | PAM |
| K243694 | Nitrile Powder Free Examination Glove With Tremella Fuciformis Extract, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate - Blue |
Mah Sing Healthcare Sdn. Bhd. |
06/06/2025 | LZA |
| K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. | 06/06/2025 | DZE |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd. | 06/06/2025 | EBF |
| K250591 | Anovo Surgical System (6Ne) | Momentis Surgical Ltd. | 06/06/2025 | QNM |
| K243994 | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. |
06/06/2025 | FLE |
| K242431 | Omnia Medical PsiF DNA™ System |
Omnia Medical, LLC | 06/06/2025 | OUR |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm |
Quanta System SpA | 06/06/2025 | GEX |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) |
Shenzhen Desida Technology Co., Ltd. |
06/06/2025 | BTA |
| K251525 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System |
SI-Technology, LLC | 06/06/2025 | OUR |
| K251009 | Cirrus Resting State Fmri Software |
Sora Neuroscience, Inc. | 06/06/2025 | QIH |
| K251131 | Annex® 2 Adjacent Level System |
Spine Wave, Inc. | 06/06/2025 | NKB |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) |
STERIS | 06/06/2025 | FRC |
| K250109 | TYBR Collagen Gel | TYBR Health | 06/06/2025 | OWY |
| K251456 | BrightHeart View Classifier | BrightHeart | 06/05/2025 | QIH |
| K242744 | Trinity EVO Acetabular Shell | Corin USA Limited | 06/05/2025 | LPH |
| K243703 | TechLive | DeepHealth, Inc. | 06/05/2025 | LLZ |
| K251084 | Zirkon; Structure; LFU Shades, Stains And Glazes |
estetic ceram ag | 06/05/2025 | EIH |
| K243667 | Sonic DL | GE Medical Systems, LLC | 06/05/2025 | LNH |
| K243639 | Portare System (FA-001) | Grumpy Innovation, Inc. | 06/05/2025 | EOB |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors |
ICU Medical, Inc. | 06/05/2025 | FPA |
| K242736 | Portable Oxygen Concentrator (Spirit-3) |
Jiangsu Yuyue Medical Equipment & Supply Co., LTD. |
06/05/2025 | CAW |
| K242464 | Stealth™ Spine Clamps; ModuLeX™ Shank Mounts |
Medtronic Navigation, Inc. |
06/05/2025 | OLO |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC |
06/05/2025 | MSX |
| K250800 | UroNav 4 | Philips DS North America LLC |
06/05/2025 | LLZ |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK) |
Shenzhen Idea Light Limited |
06/05/2025 | OAP |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR Eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) |
Surgical Instrument Service and Savings Inc. |
06/05/2025 | OWQ |
| K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | 06/05/2025 | GZI |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) |
Olympus Medical Systems Corp. |
06/05/2025 | |
| K251216 | 0184 CO2 Sampling Line; 0184T CO2 Sampling Line; 0139 CO2 Sampling Line; 0182 CO2 Sampling Line |
Barbaras Development Inc. |
06/04/2025 | CCK |
| K243810 | TraumaCad Neo (1.1) | Brainlab Ltd. | 06/04/2025 | QIH |
| K250804 | ID LIGHT CURE SYSTEM | ID KOREA CO., LTD. | 06/04/2025 | EBD |
| K240788 | Ultrasound Stimulator | JKH Health Co., Ltd. | 06/04/2025 | IMI |
| K243843 | Tendon Protect (50242) | Kerecis Limited | 06/04/2025 | OWY |
| K243368 | Montblanc Plate System | Medifield Medical Co., Ltd. |
06/04/2025 | HRS |
| K243499 | NG-Test® CTX-M MULTI | NG Biotech | 06/04/2025 | PTJ |
| K250118 | Disposable Balloon Catheter B5-2C |
Olympus Medical Systems Corporation |
06/04/2025 | EOQ |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 And MR 7700 MR System |
Philips Medical Systems Nederland B.V. |
06/04/2025 | LNH |
| K250749 | PhysCade System | PhysCade, Inc. | 06/04/2025 | DQK |
| K250961 | Blood Collection Tube Holders | Promisemed Hangzhou Meditech Co., Ltd. |
06/04/2025 | JKA |
| K250879 | Paradigm System | Proprio, Inc. | 06/04/2025 | OLO |
| K242712 | LubriZenzs | SK Zen LLC | 06/04/2025 | NUC |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) |
Surgify Medical Oy | 06/04/2025 | HBE |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation |
The ScottCare Corporation |
06/04/2025 | DRG |
| K241433 | EVE Synergy (EVE-20M) | WEERO Co.,Ltd. | 06/04/2025 | IPF |
| K250598 | Endoform Reconstructive Template - PLGA |
Aroa Biosurgery Ltd. | 06/03/2025 | FTM |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set |
Balt USA, LLC | 06/03/2025 | NRY |
| K250682 | BD Nexiva™ Diffusics™ Closed IV Catheter System And BD Nexiva™ Diffusics™ Closed IV Catheter System With BD MaxZero™ Needle-free Connector |
Becton Dickinson Infusion Therapy Systems Inc. |
06/03/2025 | FOZ |
| K250657 | Gi2000 Electrosurgical Generator |
Cintron Medical Corporation |
06/03/2025 | GEI |
| K242897 | Partial Flex | Clemde Sa De Cv | 06/03/2025 | EBI |
| K243796 | GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested For Use With Chemotherapy Drugs And Fentanyl] |
Glove One, LLC | 06/03/2025 | LZA |
| K250529 | Globe Introducer (601-01001) | Kardium Inc. | 06/03/2025 | DRA |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) |
Pentax of America, Inc | 06/03/2025 | PEA |
| K243205 | EVAC | Phasor Health, LLC | 06/03/2025 | JXG |
| K243382 | RZ Resectoscope System | RZ Medizintechnik GmbH | 06/03/2025 | HIH |
| K251035 | DISINTEK™ PA Test Strips | Serim Research | 06/03/2025 | JOJ |
| K250001 | Patriot SI Implant System | Spinal Simplicity LLC | 06/03/2025 | OUR |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) |
Acuity Surgical Devices, LLC |
06/02/2025 | MAX |
| K250452 | CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) |
MacroLux Medical Technology Co., Ltd. |
06/02/2025 | FED |
| K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop |
Science & Bio Materials (S.B.M.) SAS |
06/02/2025 | MBI |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) |
Sysmex America, Inc. | 06/02/2025 | JPA |
| K250410 | GORE® Tri-Lobe Balloon Catheter |
W. L. Gore & Associates, Inc. |
06/02/2025 | DQY |
| K251376 | LimFlow ARC | LimFlow Inc. | 05/31/2025 | PDU |
| K251406 | BriefCase-Triage | Aidoc Medical, Ltd. | 05/30/2025 | QAS |
| K242635 | Endoscopic Distal Attachment (AF-D Series) |
Alton (Shanghai) Medical Instruments Co. Ltd |
05/30/2025 | FDS |
| K250637 | VCFix Spinal System | Amber Implants | 05/30/2025 | NDN |
| K243005 | AudaxCeph Cephalogram Analysis Software |
Audax d.o.o. | 05/30/2025 | QIH |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) |
Balt USA, LLC | 05/30/2025 | KRD |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer |
Bonraybio Co., LTD. | 05/30/2025 | POV |
| K242640 | FertiCult Flushing Medium; FertiCult Flushing Medium With Phenol Red And Gentamicin |
FertiPro Nv | 05/30/2025 | MQL |
| K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC |
05/30/2025 | KDI |
| K250236 | Swoop® Portable MR Imaging® System (V2) |
Hyperfine, Inc. | 05/30/2025 | LNH |
| K242751 | ARIX Pectus Bar System | Jeil Medical Corporation | 05/30/2025 | HRS |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System With Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) |
Maquet Cardiovascular, LLC |
05/30/2025 | GEI |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) |
MateLaser, Inc. | 05/30/2025 | GEX |
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) |
Mindset Medical, Inc. | 05/30/2025 | QME |
| K242725 | Youha Electric Breast Pumps (The INs, The INs Gen2, The INs NEXT, And P3) And BEBEBAO Electric Breast Pump (P1s) |
Ningbo Youhe Electrical Appliance Technology Co.,Ltd. |
05/30/2025 | HGX |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) |
Olympus Medical Systems Corporation |
05/30/2025 | EOQ |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask With Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask With SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask With SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask With SO SOFT* Lining, With Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask With SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask With SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce |
Owens & Minor (O&M) Halyard, Inc. |
05/30/2025 | FXX |
| K243863 | Opulus™ Lymphoma Precision | Roche Molecular Systems, Inc. |
05/30/2025 | QIH |
| K250024 | TE Air Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
05/30/2025 | IYN |
| K250365 | Motif Aura Glow Breast Pump (Model Motif Aura Glow) |
Shenzhen TPH Technology Co., Ltd. |
05/30/2025 | HGX |
| K250368 | Wearable Breast Pump (Model S21) |
Shenzhen TPH Technology Co., Ltd. |
05/30/2025 | HGX |
| K250150 | VANGUARD Blood Cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set); VANGUARD Blood Cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set With Shunt); VANGUARD Blood Cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) |
Sorin Group Italia S.r.l. |
05/30/2025 | DTR |
| K250317 | EsFlow PLUS | Spident CO. LTD | 05/30/2025 | EBF |
| K243530 | Dynamic TiBase | Talladium España, SL | 05/30/2025 | NHA |
| K251063 | TekBrace Solo Soft Tissue Reinforcement Device |
TheraMicro | 05/30/2025 | QUW |
| K243522 | ViVi® Toga Premium | THI Total Healthcare Innovation GmbH |
05/30/2025 | FYA |
| K242926 | XBody Go USA, XBody Pro USA | XBody Hungary Kft. | 05/30/2025 | NGX |
| K243654 | DentalJect | Vapocoolshot, Inc | 05/30/2025 | MLY |
| K250581 | KALA Red Light Face Mask (KALA-01) |
Shenzhen Kaiyan Medical Equipment Co. Ltd. |
05/30/2025 | |
| K241313 | OHC COVID-19 Antigen Self Test | Osang LLC | 05/30/2025 | QYT |
| K243480 | SuturePatch Tissue Reinforcement |
Arthrex Inc. | 05/29/2025 | OWX |
| K251325 | VersaCross Connect™ Transseptal Dilator |
Baylis Medical Company Inc. |
05/29/2025 | DRE |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand |
Cochlear | 05/29/2025 | LXB |
| K251340 | ProSeal™ Bag Spike With Additive Port (423370ST, 423370) |
Epic Medical Pte. Ltd. | 05/29/2025 | ONB |
| K250543 | Voluson™ Performance 16; Voluson™ Performance 18 |
GE Medical Systems Ultrasound and Primary care Diagnostics |
05/29/2025 | IYN |
| K243372 | BiliWrap | Gerium Medical, Ltd. | 05/29/2025 | LBI |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental Inc. |
05/29/2025 | EIH |
| K250757 | Radius VSM And Accessories | Masimo Corporation | 05/29/2025 | MHX |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) |
Medtronic Navigation | 05/29/2025 | ONO |
| K250048 | NEUROMARK System (NMK00301) | Neurent Medical Ltd. | 05/29/2025 | GEI |
| K243469 | SIGNEX | OSTEONIC Co., Ltd. | 05/29/2025 | HRS |
| K243484 | PM2+ System And SmartPICC Stylet |
Piccolo Medical, Inc. | 05/29/2025 | LJS |
| K251315 | Anatase Spine Surgery Navigation System And Remex Spine Surgery Navigation System II |
Remex Medical Corp. | 05/29/2025 | OLO |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US |
Shanghai AnQing Medical Instrument Co., Ltd. |
05/29/2025 | EOQ |
| K243856 | TENS AND EMS (TENS And Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E, AS9026) |
Shenzhen AsTec Technology Co., Ltd. |
05/29/2025 | NUH |
| K243309 | 27G X 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) |
Terumo Europe N.V. | 05/29/2025 | FMI |
| K250606 | Dental Barrier And Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. |
05/29/2025 | PEM |
| K251344 | OptiMap™ System | Boston Scientific Corporation |
05/28/2025 | DQK |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing |
Imperative Care, Inc. | 05/28/2025 | NRY |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) |
Iradimed Corporation | 05/28/2025 | FRN |
| K243378 | Rapid MLS | iSchemaview Inc. | 05/28/2025 | QIH |
| K244049 | Europa (Alternative: AiRTouch) Portable X-ray System |
LIVERMORETECH INC | 05/28/2025 | IZL |
| K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) |
Opcom Medical Inc. | 05/28/2025 | FGB |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | 05/28/2025 | EGS |
| K250624 | Myair | ResMed Corp | 05/28/2025 | BZD |
| K242793 | InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral Is-b12a 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral Is-b22a 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral Is-b26a 6.0/3.0; InsightersTM Insight Workstation Is-pf1. |
Shenzhen Insighters Medical Technology Co., Ltd. |
05/28/2025 | EOQ |
| K250367 | CoLumboX | Smart Soft Healthcare AD | 05/28/2025 | QIH |
| K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | 05/28/2025 | MQV |
| K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. |
05/28/2025 | QKB |
| K243716 | Zionic Pro Max (Radiofrequency) |
TermoSalud S.L. | 05/28/2025 | PBX |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-2 0) |
Abbott Medical | 05/27/2025 | GXI |
| K250614 | Neodent Implant System - Custom Abutments |
JJGC Indústria e Comércia de Materiais Dentários S.A. |
05/27/2025 | NHA |
| K250932 | DeepRhythmAI | Medicalgorithmics S.A. | 05/27/2025 | DQK |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. |
05/27/2025 | EIA |
| K250475 | Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) |
NINGBO BAICHEN MEDICAL DEVICES CO., LTD |
05/27/2025 | ITI |
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V42 0Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M |
Olympus Medical Systems Corp. |
05/27/2025 | ODD |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO Ltd. | 05/27/2025 | MAI |
| K251578 | BEAUTIFIL II | Shofu Dental Corporation | 05/27/2025 | EBF |
| K243777 | Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) |
Theodent, LLC | 05/27/2025 | LBH |
| K242820 | Puritan PurSafe Plus Collection And Transport System |
Puritan Medical Products LLC |
05/27/2025 | QBD |
| K242604 | Helios+ UV-C System | PreventaMed Technologies, Inc. dba Surfacide Manufacturing |
05/27/2025 | QXJ |
| K250435 | Dexter L6 System | Distalmotion SA | 05/27/2025 | SDD |
| K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ |
Abbott Medical | 05/23/2025 | OBJ |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S |
Brain Navi Biotechnology Co., Ltd. |
05/23/2025 | HAW |
| K242594 | DEEPECHO | DeepEcho | 05/23/2025 | IYN |
| K251292 | RECLAIM Monobloc Revision Femoral Stem |
DePuy Ireland UC | 05/23/2025 | LZO |
| K250778 | Sil-Flow | DSI Dental Solutions Ltd | 05/23/2025 | EBF |
| K242545 | RadiForce MX317W-PA | EIZO Corporation | 05/23/2025 | PZZ |
| K250384 | IPL400 | EL Global Trade Ltd | 05/23/2025 | OHT |
| K250005 | Clever One | Ewoosoft Co., Ltd | 05/23/2025 | QIH |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L |
Fujifilm Corporation | 05/23/2025 | FDF |
| K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 In 1 |
GESKE Beauty Tech GmbH | 05/23/2025 | NFO |
| K243474 | MagnetOs MIS | Kuros Biosciences B.V | 05/23/2025 | MQV |
| K250239 | NeuroMatch | LVIS Corporation | 05/23/2025 | OLX |
| K243989 | Second Opinion® 3D | Pearl, Inc. | 05/23/2025 | QIH |
| K251044 | 93 NeuFlex Catheter | Piraeus Medical | 05/23/2025 | QJP |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 05/23/2025 | IYO |
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) |
Shenzhen Ulike Smart Electronics Co., Ltd. |
05/23/2025 | OHT |
| K250446 | Frida™ Anterior Cervical Plate System |
SpineUp, Inc. | 05/23/2025 | KWQ |
| K250544 | Knotilus+ Biocomposite Knotless Anchor |
Stryker Endoscopy | 05/23/2025 | MAI |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit |
The Binding Site Group Ltd |
05/23/2025 | DFH |
| K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) |
Venocare, Inc. | 05/23/2025 | JKA |
| K243023 | WiZARD 520 Full Face Mask | Wellell Inc. | 05/23/2025 | BZD |
| K250630 | Nitrile Powder-Free Exam Gloves With Hyaluronic Acid, And Tested For Use With Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid And Xylazine In Fentanyl Citrate |
Basic Medical Technology Inc. |
05/22/2025 | LZA |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) |
Clinical Innovations LLC | 05/22/2025 | HFN |
| K251493 | Skin Clinic Freeze Point For Warts And Skin Tags |
CryoConcepts LP | 05/22/2025 | GEH |
| K242684 | Harioculture TL-16 Time-lapse Incubator |
Hua Yue Medical Technology Co., Ltd. |
05/22/2025 | MQG |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd |
05/22/2025 | FLL |
| K250980 | Physica System (Physica CR Porous Femoral Components) |
Limacorporate S.p.A. | 05/22/2025 | MBH |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 05/22/2025 | MEH |
| K242586 | ArgoCap (200.52) | Ovesco Endoscopy AG | 05/22/2025 | OCX |
| K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
05/22/2025 | OHS |
| K250639 | DESS Dental Smart Solutions | Terrats Medical SL | 05/22/2025 | NHA |
| K242659 | The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Vancomycin In The Dilution Range Of 0.25-128 Ug/ml |
Thermofisher Scientific | 05/22/2025 | JWY |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) |
TriMed, Inc. | 05/22/2025 | HRS |
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter |
Urotronic, Inc. | 05/22/2025 | EZN |
| K250920 | Arthrex Spine Compression FT Screw |
Arthrex, Inc. | 05/22/2025 | MRW |
| K251230 | The Alma Hybrid Laser System | Alma Lasers, Inc | 05/21/2025 | GEX |
| K250493 | MotiliCap GI Monitoring System | AnX Robotica Corporation | 05/21/2025 | NYV |
| K242857 | ClearHemograsper | Finemedix Co., Ltd. | 05/21/2025 | KGE |
| K243762 | Synapse 3D Base Tools (V7.0) | FUJIFILM Corporation | 05/21/2025 | QIH |
| K243429 | HJY VisualNext 3D Endoscopic Vision System |
HJY Smart Medical Device Co., Ltd. |
05/21/2025 | GWG |
| K251276 | Swoop® Portable MR Imaging® System |
Hyperfine, Inc. | 05/21/2025 | LNH |
| K243116 | FlareHawk Interbody Fusion System |
Integrity Implants Inc. dba Accelus |
05/21/2025 | MAX |
| K243866 | InVision Precision Cardiac Amyloid |
InVision Medical Technology Corporation |
05/21/2025 | SDJ |
| K242637 | MEM Clear Aligner System | MEM Dental Technology Co., Ltd. |
05/21/2025 | NXC |
| K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System |
Philips Ultrasound LLC | 05/21/2025 | IYN |
| K243302 | 3DMatrix DynaFlex (DynaFlex) | PrintBio, Inc. | 05/21/2025 | OXF |
| K251109 | SMARTDent | RAY Co., Ltd. | 05/21/2025 | LLZ |
| K243122 | Umr Omega | Shanghai United Imaging Healthcare Co., Ltd. |
05/21/2025 | LNH |
| K250528 | Stryker AlphaVent™ Knotless SP Biocomposite Anchor |
Stryker Endoscopy | 05/21/2025 | MAI |
| K250798 | Control-IQ+ Technology | Tandem Diabetes Care, Inc. |
05/21/2025 | QJI |
| K251239 | GrandioSO Unlimited | VOCO GmbH | 05/21/2025 | EBF |
| K242527 | The Karma® Fixation System | Spinal Elements Inc | 05/21/2025 | MRW |
| K251231 | ViewFlex™ X ICE Catheter, Sensor Enabled™ |
Abbott Medical | 05/20/2025 | OBJ |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. |
05/20/2025 | EIH |
| K242485 | EveryWare | Breas Medical AB | 05/20/2025 | MOD |
| K250602 | X-PAC® N-GAGE™ Lumbar Plate System |
Expanding Innovations, Inc |
05/20/2025 | KWQ |
| K250243 | ProVu Single Use Video Stylet With Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet With Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet With Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet With Reinforced ET Tube (Size 8.0) (038-995-080U) |
Flexicare Medical Limited |
05/20/2025 | BTR |
| K250370 | SCENARIA View Phase 5.0 | FUJIFILM Corporation | 05/20/2025 | JAK |
| K250489 | FP3D | Keystone Industries | 05/20/2025 | EBI |
| K250199 | VitalFlow Console | Medtronic Inc | 05/20/2025 | QNR |
| K250866 | Sovereign Posterior Cervical System |
Met One Technologies, LLC |
05/20/2025 | NKG |
| K250447 | BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 Μg/ml) |
Becton, Dickinson and Company |
05/19/2025 | LON |
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) |
Gigaalaser Company Ltd. | 05/19/2025 | ILY |
| K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. |
05/19/2025 | OWB |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System |
ResMed Pty Ltd | 05/19/2025 | BZD |
| K243643 | Restor3d Reverse Total Shoulder Arthroplasty System |
restor3d | 05/19/2025 | PHX |
| K243601 | Route 92 Medical HiPoint Reperfusion System And Aspiration Tubing Set |
Route 92 Medical, Inc. | 05/19/2025 | NRY |
| K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost |
Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
05/19/2025 | IYN |
| K250122 | SleepRight Snore Aid | Splintek Inc. | 05/19/2025 | LRK |
| K243301 | MapRT | Vision RT Ltd | 05/19/2025 | IYE |
| K250038 | Muscle Stimulator Device (PZ-100) |
Zhengzhou PZ Laser Slim Technology Co., Ltd. |
05/19/2025 | NGX |
| K250390 | CloSYS® Dry Mouth Sensitive Mouth Rinse |
Rowpar Pharmaceuticals Inc. |
05/19/2025 | LFD |
| K250456 | Dentemp Pro-Comfort Dental Guard |
DOC Brands, Inc. | 05/19/2025 | OBR |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 05/16/2025 | HRX |
| K250141 | Synthecure Synthetic Calcium Sulfate |
Austin Medical Ventures, Inc. |
05/16/2025 | MQV |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | 05/16/2025 | KRD |
| K242569 | Mixed Reality Spine Navigation | Brainlab AG | 05/16/2025 | SBF |
| K242438 | Clearo | Breas Medical AB | 05/16/2025 | NHJ |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 |
Byonyks Pvt Ltd | 05/16/2025 | FKX |
| K243176 | BLESSING System | Cellah Medical Co., Ltd. | 05/16/2025 | GEI |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System |
Encore Medical, L.P. | 05/16/2025 | PHX |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) |
Esaote S.p.A. | 05/16/2025 | IYN |
| K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation |
05/16/2025 | MSD |
| K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. |
05/16/2025 | OEB |
| K243837 | Ibsm | iOrbit Digital Technologies Private Limited |
05/16/2025 | DRG |
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) |
Medicatech USA Inc. | 05/16/2025 | OWB |
| K250086 | OTS Hip | Ortoma AB | 05/16/2025 | OLO |
| K244008 | Spectral CT | Philips Medical Systems Technologies Ltd. |
05/16/2025 | JAK |
| K242585 | Cystatin C | Sentinel CH. S.p.A. | 05/16/2025 | NDY |
| K243617 | Uct ATLAS Astound With Uws-ct-dual Energy Analysis; Uct ATLAS With Uws-ct-dual Energy Analysis |
Shanghai United Imaging Healthcare Co.,Ltd. |
05/16/2025 | JAK |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA6 05,NASA606,NASA608,NASA610) |
Shenzhen Desida Technology Co., Ltd. |
05/16/2025 | BTA |
| K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
05/16/2025 | IYN |
| K250099 | Mobius3D (4.1) | Varian Medical Systems | 05/16/2025 | IYE |
| K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 05/16/2025 | FOZ |
| K243927 | MobileLink Acetabular Cup System - Inhouse Coatings |
Waldemar Link GmbH & Co.KG |
05/16/2025 | LZO |
| K242706 | Lumipulse G Ptau217/ß-amyloid 1-42 Plasma Ratio |
Fujirebio Diagnostics, Inc. |
05/16/2025 | QSE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) |
C. R. Bard, Inc. | 05/15/2025 | LDF |
| K242518 | Hypertension Prediction Index (HePI) Algorithm |
Edwards Lifesciences LLC | 05/15/2025 | QAQ |
| K250276 | Nitinol Enhanced Device (NED) | Embolization Inc. | 05/15/2025 | KRD |
| K243165 | Limfa Therapy System (Limfa Therapy) |
EYWA srl | 05/15/2025 | NGX |
| K251156 | NPseal | Guard Medical, Inc. | 05/15/2025 | OKO |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) |
Hardy Diagnostics | 05/15/2025 | JTN |
| K242931 | HFT750U | MEKICS Co., Ltd. | 05/15/2025 | MNT |
| K250444 | NEXUS® Hip Stem | MicroPort Orthopedics, Inc. |
05/15/2025 | LZO |
| K250451 | NeurAxis IB-Stim (01-1020) | NeurAxis | 05/15/2025 | QHH |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) |
NIKKISO CO., LTD. | 05/15/2025 | KDI |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) |
Nikkiso Co., LTD. | 05/15/2025 | KOC |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU |
Nikkiso Co., LTD. | 05/15/2025 | KOC |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) |
Olympus Medical Systems Corporation |
05/15/2025 | FDF |
| K242519 | Lumify Diagnostic Ultrasound System |
Philips Ultrasound | 05/15/2025 | IYN |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) |
Stryker Instruments | 05/15/2025 | GXI |
| K240857 | Youmagic FLM System (YM5-U1) | WE Medical Technology (Wuxi) Co., Ltd. |
05/15/2025 | GEI |
| K250813 | MICROLET®NEXT 2 Lancing Device |
Ascensia Diabetes Care US Inc |
05/14/2025 | QRL |
| K242072 | CeraRoot TL Implant System (TL) |
CeraRoot SL | 05/14/2025 | DZE |
| K242437 | Smile Dx® | Cube Click, Inc. | 05/14/2025 | MYN |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) |
Ethicon Endo-Surgery, LLC |
05/14/2025 | GDW |
| K250420 | Helios Dura Regeneration Matrix |
Helios Biomedical Inc. | 05/14/2025 | GXQ |
| K250775 | Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System |
Imperative Care, Inc. | 05/14/2025 | QEW |
| K242624 | Medical Image Post-processing Software (uOmnispace.CT) |
Shanghai United Imaging Healthcare Co., Ltd. |
05/14/2025 | QIH |
| K243830 | Disposable Ureteral Stent | Shenzhen Trious Medical Technology Co., Ltd |
05/14/2025 | FAD |
| K250533 | Magnesium Alloy Scooter (RS100) |
Taizhou Reach Technology Co., Ltd |
05/14/2025 | INI |
| K250405 | Nerivio; Nerivio Infinity | Theranica Bio-Electronics Ltd |
05/14/2025 | QGT |
| K250712 | Linkt Compression Staple System |
Trax Surgical | 05/14/2025 | JDR |
| K250414 | CaloPix | Tribun Health | 05/14/2025 | QKQ |
| K251288 | Veincare | WONTECH CO., LTD. | 05/14/2025 | GEX |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) |
Zhengzhou PZ Laser Slim Technology Co., Ltd. |
05/14/2025 | GEX |
| K242762 | Aesculap Aicon® Series Container System |
Aesculap Inc. | 05/13/2025 | KCT |
| K242808 | Aplio I900/i800/i700 Diagnostic Ultrasound System, Software V8.5 |
Canon Medical Systems Corporation |
05/13/2025 | IYN |
| K250786 | SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. | 05/13/2025 | NAY |
| K251138 | Promisemed Safety Huber Needles |
Promisemed Hangzhou Meditech Co., Ltd. |
05/13/2025 | PTI |
| K242674 | Freedom Posterior Cervical Screws |
Signature Orthopaedics Pty Ltd |
05/13/2025 | NKG |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) |
Ulthera Inc. | 05/13/2025 | OHV |
| K243509 | Archer PSI System | 3D-Side | 05/12/2025 | QHE |
| K244050 | AYON Body Contouring System (AYON SYSTEM) |
Apyx Medical Corporation | 05/12/2025 | QPB |
| K250763 | Reon | C.E.I.B.med | 05/12/2025 | EBF |
| K250868 | SPECTRALIS HRA+OCT And Variants |
Heidelberg Engineering GmbH |
05/12/2025 | OBO |
| K250421 | InThrill™ Thrombectomy System |
Inari Medical, Inc. | 05/12/2025 | QEW |
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) |
Northeast Scientific, Inc. |
05/12/2025 | OWQ |
| K242418 | P-Cure Proton Therapy System (PPTS) |
P-Cure, Ltd. | 05/12/2025 | LHN |
| K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) |
Shandong Moonlight Electronics Tech Co.,Ltd. |
05/12/2025 | GEX |
| K243632 | Uws-angio Basic | Shanghai United Imaging Healthcare Co., Ltd. |
05/12/2025 | LLZ |
| K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty Ltd |
05/12/2025 | MBI |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia |
United Zirconia | 05/12/2025 | EIH |
| K250360 | TENS AND EMS (TENS And Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026 ) |
Shenzhen Jiantuo Electronics Co., Ltd. |
05/11/2025 | NUH |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test |
ACON Laboratories, Inc. | 05/10/2025 | SCA |
| K243322 | Altaviz Intravitreal Syringe | Altaviz, LLC | 05/09/2025 | QLY |
| K241086 | Avidhrt Sense SpO2 | Avidhrt Inc. | 05/09/2025 | DQA |
| K242388 | LensHooke X12 PRO Semen Analysis System |
Bonraybio Co., LTD. | 05/09/2025 | POV |
| K243290 | BTL-785MJ | BTL Industries, Inc. | 05/09/2025 | NUW |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC. |
05/09/2025 | FPA |
| K250758 | Electric Wheelchair (F309) | CHANGSHU PINGFANG WHEELCHAIR CO., LTD |
05/09/2025 | ITI |
| K242392 | PATH BGC | Crossroads Neurovascular, Inc. |
05/09/2025 | QJP |
| K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls |
DiaSys Diagnostic Systems GmbH |
05/09/2025 | PTF |
| K243107 | Water Solubility Human Body Lubricant |
Dongguan Yanxuan Biotechnology Co., Ltd. |
05/09/2025 | NUC |
| K251126 | SKOUT System | Iterative Health | 05/09/2025 | QNP |
| K251425 | Turbodent Touch | Mectron S.p.A | 05/09/2025 | KOJ |
| K243230 | Second Opinion® BLE | Pearl Inc. | 05/09/2025 | QIH |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) |
Philips Image Guided Therapy Corporation |
05/09/2025 | OBJ |
| K250053 | TENS AND EMS (TENS And Muscle Stimulator) (JT8012, JT8012B) |
Shenzhen Jiantuo Electronics Co., Ltd. |
05/09/2025 | NUH |
| K250299 | CT/ MR Tandem And Ovoid Set | Varian Medical Systems, Inc. |
05/09/2025 | JAQ |
| K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) |
Vigeon Technology Co., Ltd. |
05/09/2025 | GEI |
| K243812 | Volta AF-Xplorer | Volta Medical | 05/09/2025 | DQK |
| K242732 | Tristel OPH | Tristel Solutions Ltd. | 05/09/2025 | QWS |
| K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems |
Philips Ultrasound LLC | 05/09/2025 | |
| K243419 | Altus Spine Navigation System | Altus Partners LLC. | 05/08/2025 | OLO |
| K250582 | COLONNADE Posterior Screw Fixation System |
CG Bio Co., Ltd. | 05/08/2025 | NKB |
| K250226 | Clarius Median Nerve AI | Clarius Mobile Health Corp. |
05/08/2025 | QIH |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue |
Fissiontech LLC | 05/08/2025 | LRK |
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) |
Leltek Inc. | 05/08/2025 | IYN |
| K242410 | NextStep Arthropedix Total Knee System |
NextStep Arthropedix | 05/08/2025 | JWH |
| K242670 | Lumify Diagnostic Ultrasound System |
Philips Ultrasound | 05/08/2025 | IYN |
| K243824 | Preat Abutments | Preat Corporation | 05/08/2025 | NHA |
| K243110 | Efoldi Navigator Powerchair (STPC-A) |
SunTech UK Ltd. | 05/08/2025 | ITI |
| K233271 | OsseOne Dental Implant System | Synoross DBA OsseOne | 05/08/2025 | DZE |
| K251133 | AVEA Disposable Expiratory Filter/water Trap (11790) |
Telesair Inc. | 05/08/2025 | CBK |
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UT U3-G7W,UTU-G20B,UTU-G20W) |
Wuhan Pioon Technology Co., Ltd. |
05/08/2025 | NVK |
| K250222 | SDF Pro | Belport Company, Inc., Gingi-Pak |
05/07/2025 | PHR |
| K243684 | BrightHeart View Classifier | BrightHeart | 05/07/2025 | QIH |
| K251111 | Cary | Excitus AS | 05/07/2025 | JCX |
| K251128 | Extremity Medical External Fixation System |
Extremity Medical, LLC | 05/07/2025 | KTT |
| K242975 | Mobility Scooter (Model X-01, X-02) |
Wuyi Aichi Industry & Trade Co., Ltd. |
05/07/2025 | INI |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) |
ZEUS Scientific | 05/07/2025 | MOB |
| K250253 | IPL Hair Removal Device (KCA511/KCA516/KCA522) |
Dongguan Boyuan Intelligent Technology Co.,Ltd |
05/06/2025 | OHT |
| K243017 | IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) |
Foshan Newface Electronic Technology Co., Ltd. |
05/06/2025 | OHT |
| K250785 | Single-use Flexible Ureteroscope |
Hunan Vathin Medical Instrument Co.Ltd |
05/06/2025 | FGB |
| K250160 | ANKYRAS | Mentice Spain S.L. | 05/06/2025 | PZO |
| K241980 | !M1 | Solutions for tomorrow AB |
05/06/2025 | IZL |
| K251094 | Alma Veil | Won Tech Co., Ltd. | 05/06/2025 | GEX |
| K243603 | AeviceMD | Aevice Health Pte. Ltd. | 05/05/2025 | DSH |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging System |
Arthrex, Inc. | 05/05/2025 | GCJ |
| K243370 | DentaTOOTH | Asiga Pty Ltd | 05/05/2025 | EBG |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) |
DAE MYUNG CHEMICAL CO., LTD. (VIETNAM) |
05/05/2025 | FYA |
| K242386 | Bluemoon | GENOSS Co., Ltd. | 05/05/2025 | EBZ |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | 05/05/2025 | MYN |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) |
Philips Medizin Systeme Böblingen GmbH |
05/05/2025 | MHX |
| K240447 | ThermoChem HT-2000 System And Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) |
ThermaSolutions, LLC | 05/05/2025 | MLW |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) |
ZAMAR Medical d.o.o. | 05/05/2025 | IRP |
| K244014 | I-stat CG4+ Cartridge With The I-stat 1 System |
Abbott Point of Care Inc. |
05/02/2025 | CHL |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | ATsens Co.,Ltd. | 05/02/2025 | DSH |
| K242986 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. |
05/02/2025 | DSA |
| K251071 | Fetal EchoScan (v1.1) | BrightHeart | 05/02/2025 | POK |
| K243828 | CIONIC NEURAL SLEEVE (NS-200) | CIONIC Inc. | 05/02/2025 | GZI |
| K250629 | Sutil Rich Personal Lubricant | Hathor Professional Skincare Ltd. |
05/02/2025 | NUC |
| K243069 | LUMYS (V1) | INTRADYS | 05/02/2025 | LLZ |
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) |
KARL STORZ SE & CO. KG | 05/02/2025 | FBO |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems Ltd. |
05/02/2025 | POV |
| K251056 | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode |
Momentis Surgical Ltd. | 05/02/2025 | QNM |
| K242763 | JetCan® Pro Safety Huber Needle |
PFM Medical, Inc | 05/02/2025 | FPA |
| K243894 | F88 URE-SD/RD Flexible Ureteroscope |
SG Endoscopy Pte Ltd | 05/02/2025 | FGB |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo |
Shenzhen AOJ Medical Technology Co., Ltd. |
05/02/2025 | DXN |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 05/02/2025 | DQY |
| K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty Ltd |
05/02/2025 | LZO |
| K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) |
SkyDance Vascular, Inc. | 05/02/2025 | FOZ |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 |
STERIS Corporation | 05/02/2025 | JOJ |
| K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel |
Seriously Clean, Ltd | 05/02/2025 | FRO |
| K242315 | Resolve Modular Revision Hip Stem |
United Orthopedic Corporation |
05/01/2025 | MEH |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution |
Traferox Technologies Inc. |
05/01/2025 | KDN |
| K244020 | Wrinkle Treatment Device (JM1, JM2B) |
Shenzhen Qianyu Technology Co., Ltd. |
05/01/2025 | OHS |
| K250641 | APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. | 05/01/2025 | HSN |
| K250296 | Disposable Distal Attachment D-201 Series |
Olympus Medical Systems Corp. |
05/01/2025 | FDS |
| K250029 | ONE TRAY® Sealed Sterilization Container System |
Innovative Sterilization Technologies |
05/01/2025 | KCT |
| K250087 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics |
05/01/2025 | IYN |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) |
Circa Scientific, Inc. | 05/01/2025 | DXF |
| K250996 | Xpert Xpress CoV-2/Flu/RSV Plus |
Cepheid® | 05/01/2025 | QOF |
| K250995 | Xpert Xpress CoV-2/Flu/RSV Plus |
Cepheid® | 05/01/2025 | QOF |
| K243521 | Conical Ti Base Abutments | BioHorizons Implant Systems Inc. |
05/01/2025 | NHA |
| K251014 | APRO 45 Catheter | Alembic, LLC | 05/01/2025 | DQY |
| K250282 | Persona C HR | A.T.S. Applicazione Tecnologie Speciali s.r.l. |
04/30/2025 | OWB |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin |
Aidite (Qinhuangdao) Technology Co., Ltd |
04/30/2025 | EBF |
| K251015 | APRO 45 Catheter And Alembic Aspiration Tubing |
Alembic, LLC | 04/30/2025 | NRY |
| K250274 | ETEST Imipenem/Relebactam P. Aeruginosa (IRPA) (0.008/4-128/4 Μg/ml) |
bioMerieux, SA | 04/30/2025 | JWY |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program |
Canon Medical Systems Corporation |
04/30/2025 | QIH |
| K251051 | AuST Steerable Sheath | CenterPoint Systems LLC | 04/30/2025 | DYB |
| K243541 | LumiRex Bronchoscope | Contra Healthcare Solutions, LLC |
04/30/2025 | EOQ |
| K250295 | Dentsply Sirona Titanium Bases System |
Dentsply Sirona | 04/30/2025 | NHA |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge |
Haemonetics | 04/30/2025 | JPA |
| K243942 | Arctic Sun Stat Temperature Management System |
Medivance, Inc. | 04/30/2025 | DWJ |
| K243934 | Stable-L Lumbar Interbody System |
Nexus Spine, LLC | 04/30/2025 | OVD |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | 04/30/2025 | HKI |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); |
Shenzhen AOJ Medical Technology Co., LTD |
04/30/2025 | DXN |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set |
Sol-Millennium Medical, Inc. |
04/30/2025 | JKA |
| K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | 04/29/2025 | DQY |
| K242211 | PUMA-G Pediatric System | CoapTech Inc. | 04/29/2025 | KGC |
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile And Protein Claim Of 50 Micrograms Per Dm2 Or Less Protein |
Comfort Rubber Gloves Industries Sdn. Bhd. |
04/29/2025 | LYY |
| K250308 | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) |
Dongguan Boyuan Intelligent Technology Co., Ltd. |
04/29/2025 | OAP |
| K242354 | AllNEB | Enchant Tek Co. Ltd. | 04/29/2025 | CAF |
| K243886 | ExpressCore Biopsy Device | INRAD, Inc | 04/29/2025 | KNW |
| K242255 | Qitexio® 4-Way Stopcock (QIT014) |
Medex | 04/29/2025 | FMG |
| K243963 | Pediatric Plating Platform Hip | OrthoPediatrics Corp. | 04/29/2025 | HRS |
| K250617 | Apex Flex | SprintRay Inc. | 04/29/2025 | EBI |
| K242495 | LMA Fastrach ETT SU | Teleflex Medical | 04/29/2025 | BTR |
| K243896 | LenSx Laser System (8065998162) |
Alcon Laboratories, Inc. | 04/28/2025 | OOE |
| K250958 | APRO 55 Swift Catheter And Alembic Aspiration Tubing |
Alembic, LLC | 04/28/2025 | NRY |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) And Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) |
AventaMed DAC | 04/28/2025 | ETD |
| K242951 | Diode Laser Hair Removal Machine (QDTM-02) |
Beijing Nubway S&T Co., Ltd. |
04/28/2025 | GEX |
| K243532 | LumiRex Ureteroscope | Contra Healthcare Solutions, LLC |
04/28/2025 | FGB |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System |
Eminent Spine | 04/28/2025 | NKB |
| K250030 | Flash Ultrasound System 5100 Point Of Care |
Philips Ultrasound LLC | 04/28/2025 | IYN |
| K243376 | Uangio AVIVA CX | Shanghai United Imaging Healthcare Co.,Ltd. |
04/28/2025 | OWB |
| K250977 | Suture-TOOL System | Suturion AB | 04/28/2025 | NEW |
| K250158 | Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) |
Zhe jiang Cleisman Industry and Trade Co.,LTD |
04/28/2025 | ITI |
| K251101 | AIRO Suction Unit (AIRO-01) | CRO, LLC | 04/26/2025 | BTA |
| K251117 | Cervical Spine Truss System (CSTS) |
4WEB Medical | 04/25/2025 | OVE |
| K243821 | I-cut | A.M.I. Agency for Medical Innovations GmbH |
04/25/2025 | HET |
| K250426 | Amulet™ Steerable Delivery Sheath |
Abbott Medical | 04/25/2025 | DQY |
| K242469 | RFMagik Lite | Agnes Medical Co., Ltd | 04/25/2025 | GEI |
| K243041 | Contact Forte Alpha | BHM-Tech Produktionsgesellschaft mbH |
04/25/2025 | LXB |
| K250723 | FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) |
Cardio Flow Inc. | 04/25/2025 | MCW |
| K243855 | BD Alaris Infusion System With Guardrails Suite MX |
CareFusion 303, Inc. | 04/25/2025 | FRN |
| K250554 | Prodisc® L Instruments | Centinel Spine LLC | 04/25/2025 | QLQ |
| K243861 | Butterflybvm | Compact Medical, Inc. | 04/25/2025 | BTM |
| K242321 | Kosmos | EchoNous, Inc. | 04/25/2025 | IYN |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd |
04/25/2025 | FLL |
| K243998 | DCX Disposable Cassette (DCX) | Institut Geroges Lopez | 04/25/2025 | KDN |
| K250892 | CastleLoc Pectus Bar System | L&K Biomed Co., Ltd. | 04/25/2025 | HRS |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer |
Mako Surgical Corp. | 04/25/2025 | OLO |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer |
Merit Medical Systems, Inc. |
04/25/2025 | DYB |
| K244026 | PAL 7020 Console | MicroAire Surgical Instruments, LLC |
04/25/2025 | QPB |
| K250153 | Neu Platform | Neuhealth Digital Ltd. | 04/25/2025 | GYD |
| K251075 | DYNAMIS™ Implant System | Promethean Restorative LLC |
04/25/2025 | OUR |
| K243400 | Cobas Liat SARS-CoV-2 & Influenza A/B V2 Nucleic Acid Test |
Roche Molecular Systems, Inc. |
04/25/2025 | QOF |
| K243406 | Cobas Liat SARS-CoV-2, Influenza A/B & RSV Nucleic Acid Test |
Roche Molecular Systems, Inc. |
04/25/2025 | QOF |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) |
Shenzhen Urion Technology Co., Ltd. |
04/25/2025 | IRP |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex Reagent Cartridge (TSHL); Dimension LOCI Free Thyroxine Flex Reagent Cartridge (FT4L) |
Siemens Healthcare Diagnostics |
04/25/2025 | JLW |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) |
Sorin Group Italia S.r.l. |
04/25/2025 | KDI |
| K243876 | VERIFY STEAM Integrating Indicator |
STERIS Corporation | 04/25/2025 | JOJ |
| K250289 | Intracavitary/Interstitial System |
Varian Medical Systems | 04/25/2025 | JAQ |
| K243721 | Self Sealing Sterilization Pouches |
Wellmed Dental Medical Supply Co., Ltd |
04/25/2025 | FRG |
| K242973 | CanMINI Hand And Foot System | CANWELL MEDICAL CO., LTD. |
04/24/2025 | HRS |
| K243954 | PeriCross™ Epicardial Access Kit |
CIRCA Scientific, Inc. | 04/24/2025 | DYB |
| K243239 | Lung AI (LAI001) | Exo Inc | 04/24/2025 | MYN |
| K233337 | Freespira Breathing System | Freespira, Inc | 04/24/2025 | SEN |
| K250262 | GO-PEN® | GO-Pen ApS | 04/24/2025 | FMF |
| K243714 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 04/24/2025 | NAY |
| K250206 | Diode Laser System (Night Universe; Predator) |
Ivylaser (Beijing) Technology Co.,Ltd |
04/24/2025 | GEX |
| K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | 04/24/2025 | CCL |
