IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K241628 | YO Home Sperm Test | Medical Electronic Systems Ltd. |
11/29/2024 | POV |
| K241090 | Evie Med Ring | Movano Inc. dba Movano Health |
11/29/2024 | DQA |
| K243375 | Ruthless Spine RJB | Ruthless, LLC dba Ruthless Spine |
11/29/2024 | QWL |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter |
Surgical Instrument Service and Savings Inc. |
11/29/2024 | NLH |
| K241353 | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set |
Bard Access Systems, Inc. |
11/27/2024 | PTI |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) |
Cellmyx | 11/27/2024 | QPB |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902) |
CERAGEM Co, Ltd. | 11/27/2024 | JFB |
| K242187 | BioBrace® | CONMED Corporation | 11/27/2024 | OWW |
| K243362 | SmoothSkin Pure Switch (SSC1) | CyDen Limited | 11/27/2024 | OHT |
| K243354 | Remunity System | DEKA Research & Development Corp. |
11/27/2024 | QJY |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE) |
EasyMed Instruments Co., Ltd. |
11/27/2024 | KPI |
| K243221 | RadiForce RX570; RadiForce RX570-AR |
EIZO Corporation | 11/27/2024 | PGY |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) |
KARL STORZ SE & CO. KG | 11/27/2024 | FBO |
| K240994 | Nexpowder | Nextbiomedical Co., Ltd. | 11/27/2024 | QAU |
| K240645 | Sonix Health | Ontact Health Co., Ltd | 11/27/2024 | QIH |
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim |
Prevest Denpro Limited | 11/27/2024 | EBF |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
11/27/2024 | IYN |
| K242796 | CryoGlow (FW3XXXX) | SharkNinja Operating, LLC |
11/27/2024 | OHS |
| K242638 | LED Light Therapy Machine (G1, G3, G4, G6) |
Shenzhen Walton Technology Co., Ltd. |
11/27/2024 | OHS |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter |
Spectrum Vascular | 11/27/2024 | FOZ |
| K243408 | TACTIX Vector Syndesmosis System |
Vilex LLC | 11/27/2024 | |
| K242308 | Power Wheelchair | Zhejiang Zhonglei Medical Technology Co. Ltd. |
11/27/2024 | ITI |
| K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) |
ASG Superconductors S.P.A. |
11/26/2024 | LNH |
| K243191 | Atlas Spine Lateral Expandable Interbody System |
Atlas Spine, Inc. | 11/26/2024 | OVD |
| K243193 | Cross Wise™ Multi-Use RF Adapter Cable |
Circa Scientific, Inc. | 11/26/2024 | DXF |
| K242049 | SureCath Set | Coloplast Corp | 11/26/2024 | EZD |
| K231859 | PrimmaArt | DentsCare LTDA | 11/26/2024 | EBG |
| K241995 | HyperFlex™ Bunion Correction System |
FootBridge Medical | 11/26/2024 | HRS |
| K242318 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 11/26/2024 | NAY |
| K241390 | NeuroMatch | LVIS Corporation | 11/26/2024 | OMB |
| K242810 | RadUnity (Version 1.0.0) | RadUnity Corp. | 11/26/2024 | LLZ |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct |
Riverpoint Medical LLC | 11/26/2024 | MBI |
| K243118 | Arm Blood Pressure Monitor (model: BPM-A7VL) |
Shenzhen IMDK Medical Technology Co., Ltd. |
11/26/2024 | DXN |
| K242631 | REGENETEN™ Bioinductive Implant |
Smith & Nephew Inc., Endoscopy Div. |
11/26/2024 | OWY |
| K231655 | 4CIS® Chiron Spinal Fixation System |
Solco Biomedical Co., Ltd. |
11/26/2024 | NKB |
| K242559 | Digital Temp | SprintRay Inc. | 11/26/2024 | EBG |
| K240818 | R2P Radifocus Glidewire Advantage |
Terumo Corporation | 11/26/2024 | DQX |
| K242657 | The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Daptomycin In The Dilution Range Of 0.03-64 Ug/ml |
Thermofisher Scientific | 11/26/2024 | JWY |
| K240650 | LungProtect | Traferox Technologies Inc. |
11/26/2024 | KDN |
| K243050 | TriMed Posterior Malleolus Fixation System |
TriMed, Inc. | 11/26/2024 | HRS |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | 11/26/2024 | JAQ |
| K240897 | Cellinew | Viol Co. Ltd | 11/26/2024 | GEI |
| K242538 | 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M |
3M Company | 11/25/2024 | FRC |
| K242245 | Customized Abutment | ARUM DENTISTRY Co., Ltd. | 11/25/2024 | NHA |
| K241692 | MIS LYNX Conical Connection Implant System |
Dentsply Sirona Inc. | 11/25/2024 | DZE |
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) |
eemagine Medical Imaging Solutions GmbH |
11/25/2024 | GXY |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis |
FH Industrie | 11/25/2024 | PHX |
| K242971 | AccurSound Electronic Stethoscope (AS101) |
Heroic Faith International Ltd. |
11/25/2024 | DQD |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay |
Hologic, Inc. | 11/25/2024 | PQA |
| K232588 | Aluna 2 | Knox Medical Diagnostics | 11/25/2024 | BZH |
| K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical Inc. | 11/25/2024 | QEY |
| K241831 | Transpara (2.1.0) | ScreenPoint Medical B.V. | 11/25/2024 | QDQ |
| K232982 | EMS Sculpt Machine | Shandong Huamei Technology Co.,Ltd. |
11/25/2024 | NGX |
| K243162 | World Liner | Signature Orthopaedics Pty Ltd |
11/25/2024 | MEH |
| K241588 | Electric Wheelchair (KR8803) | Zhejiang Kairui Medical Device Co., Ltd |
11/25/2024 | ITI |
| K242927 | Suction Irrigation Tubing Set | Advamedix, GmbH | 11/22/2024 | GCJ |
| K242884 | Additively Manufactured Denture Resin |
Aidite (Qinhuangdao) Technology Co., Ltd. |
11/22/2024 | EBI |
| K242203 | BriefCase-Quantification | Aidoc Medical, Ltd. | 11/22/2024 | QIH |
| K242094 | Dreem 3S | Beacon Biosignals, Inc. | 11/22/2024 | OLZ |
| K242259 | Cala Kiq | Cala Health, Inc. | 11/22/2024 | QBC |
| K242002 | FemVue MINI Saline-Air Device | Femasys Inc. | 11/22/2024 | LKF |
| K233567 | OsteoCoil™ Nitinol Compression System (Multiple Component PNs) |
Flower Orthopedics Corporation DBA Conventus Flower Ortho |
11/22/2024 | HWC |
| K242968 | Giftlife® Single-Step Medium Plus |
Gimbo Medical Technology Shenzhen Co., Ltd. |
11/22/2024 | MQL |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 11/22/2024 | KNT |
| K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited |
11/22/2024 | LBH |
| K240632 | Neuvotion NeuStim NN-01 | Neuvotion Inc. | 11/22/2024 | GZI |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer |
Nova Biomedical Corporation |
11/22/2024 | LCP |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology |
PAJUNK GmbH Medizintechnologie |
11/22/2024 | BSP |
| K242722 | Manual Wheelchair (MASY23) | Sichuan AST Medical Equipment Co., Ltd |
11/22/2024 | IOR |
| K243334 | Nooro Body & Foot Stimulator (SM9141, SM9142) |
XF Agencija Limited | 11/22/2024 | NUH |
| K241529 | Powered Wheelchair (NXN20-209) | Zhejiang Nysin Medical Co., Ltd. |
11/22/2024 | ITI |
| K242543 | Persona The Personalized Knee System (Persona Ti-Nidium PPS Femurs) |
Zimmer, Inc. | 11/22/2024 | MBH |
| K243405 | Xpert Vana | Cepheid® | 11/21/2024 | NIJ |
| K241210 | Luja Coude | Coloplast Corp | 11/21/2024 | EZD |
| K242871 | ATTUNE™ Revision Hinge Knee | DePuy Ireland UC | 11/21/2024 | JWH |
| K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber |
Fink Engineering Pty Ltd | 11/21/2024 | CBF |
| K242553 | MIRARI® Cold Plasma System ( GV-M2-01) |
General Vibronics, Inc. | 11/21/2024 | PBX |
| K242596 | Versalock Mini And Micro Plating System |
GM Dos Reis Industria e Comercio Ltda |
11/21/2024 | HRS |
| K242998 | GMReis Ankle Plating System | GM Dos Reis Industria e Comercio Ltda |
11/21/2024 | HRS |
| K241157 | Secret MAX Multi-platform RF System |
Ilooda Co,.Ltd. | 11/21/2024 | GEI |
| K241495 | Jazz Classic | Jazz Imaging | 11/21/2024 | LLZ |
| K241319 | SKR 3000 | Konica Minolta, Inc. | 11/21/2024 | MQB |
| K242799 | PliaFX Flo | LifeNet Health | 11/21/2024 | MBP |
| K232520 | Fingertip Pulse Oximeter, Models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH |
Shenzhen Smallsignal Technology Co., Ltd. |
11/21/2024 | DQA |
| K242414 | TiLink-P Joint Fusion System | SurGenTec LLC | 11/21/2024 | OUR |
| K242874 | Gating Reflector Block | Varian Medical Systems, Inc. |
11/21/2024 | JAK |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test |
Eterbio, Inc. | 11/20/2024 | NGL |
| K242359 | Strain AI (SAI001) | Exo Inc | 11/20/2024 | QIH |
| K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd | 11/20/2024 | BZG |
| K243164 | INDIBA COMPACT Devices | INDIBA S. A. U. | 11/20/2024 | PBX |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds |
Osartis GmbH | 11/20/2024 | MBB |
| K242521 | Estar-ZE | Osstem Implant Co., Ltd. | 11/20/2024 | EIH |
| K242520 | Element Vascular Access System | Penumbra, Inc. | 11/20/2024 | DYB |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | 11/20/2024 | OVE |
| K240746 | Neurovascular Access System Family |
Q'Apel Medical, Inc. | 11/20/2024 | QJP |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
11/20/2024 | OAP |
| K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) |
Shenzhen Ruiyi Business Technology Co., Ltd. |
11/20/2024 | IRP |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis |
Smith & Nephew, Inc. | 11/20/2024 | |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) W/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) W/o Needle, SOL-M Luer Lock Syringe (Low Dead Space) W/exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) W/safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) W/exchangeable Needle |
Sol-Millennium Medical Inc. |
11/20/2024 | QNQ |
| K241603 | Powered Wheelchair (NXN20-208, NXN20-211) |
Zhejiang Nysin Medical Co., Ltd. |
11/20/2024 | ITI |
| K243045 | “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) |
BRAXX Biotech Co. Ltd | 11/19/2024 | JAQ |
| K242102 | CerroZone Mini | CerroZone LLC | 11/19/2024 | FRF |
| K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) |
Dongguanshi Yiyingmei Technology Co., Ltd. |
11/19/2024 | BTA |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) |
Eieling Technology (Shenzhen) Limited |
11/19/2024 | IYO |
| K243277 | Freedom® Medial Congruent Liner |
Maxx Orthopedics, Inc. | 11/19/2024 | JWH |
| K242516 | EUROPA™ Posterior Cervical Fusion System |
MiRus, LLC | 11/19/2024 | NKG |
| K242930 | Natus BrainWatch System | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
11/19/2024 | OMC |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer |
Nova Biomedical Corporation |
11/19/2024 | |
| K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 11/19/2024 | MOS |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) |
Rhein Laser Technologies Co., Ltd. |
11/19/2024 | GEX |
| K243323 | Iconix Knotless Anchor | Riverpoint Medical | 11/19/2024 | MBI |
| K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
11/19/2024 | IYN |
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
11/19/2024 | PZI |
| K241747 | Saige-Dx | DeepHealth, Inc | 11/18/2024 | QDQ |
| K240871 | Synxess Neurovascular Guidewire |
Enlight Medical Technologies (Shenzhen) Co., Ltd. |
11/18/2024 | MOF |
| K241498 | Diode Laser Treatment System (K18) |
Hebei Keylaser Sci-Tech Co., Ltd. |
11/18/2024 | GEX |
| K241814 | Da Vinci SP Instruments (SP1098) |
Intuitive Surgical, Inc. | 11/18/2024 | NAY |
| K241633 | Informed Vital Core Application (IVC App) |
Mindset Medical, Inc. | 11/18/2024 | QME |
| K243506 | Montage-XT Settable Bone Putty | Orthocon Inc. | 11/18/2024 | MQV |
| K242329 | CT Collaboration Live | Philips Healthcare (Suzhou) Co., Ltd |
11/18/2024 | LLZ |
| K242092 | MICRO Arterial Filters | Sorin Group Italia S.r.l. |
11/18/2024 | DTM |
| K241700 | Tenex 2nd Generation System | Trice Medical, Inc. | 11/18/2024 | LFL |
| K243320 | Air Pressure Therapy System (VU-IPC04B) |
Xiamen WeiYou Intelligent Technology Co.,Ltd. |
11/18/2024 | IRP |
| K242471 | Power Wheelchair (W5538) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
11/18/2024 | ITI |
| K242402 | Power Wheelchair | Zhejiang Zhonglei Medical Technology Co.Ltd. |
11/18/2024 | ITI |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay |
Hologic, Inc. | 11/15/2024 | QOF |
| K240528 | B-one® Total Hip System | b-ONE Ortho, Corp. | 11/15/2024 | LZO |
| K242272 | CORIOGRAPH Pre-Op Planning And Modeling Services |
Blue Belt Technologies, Inc. |
11/15/2024 | OLO |
| K242960 | AdVance™ XP Male Sling System (720163-03) |
Boston Scientific Corporation |
11/15/2024 | OTM |
| K242260 | Aprevo® Cervical ACDF; Aprevo® Cervical ACDF-X; Aprevo® Cervical ACDF-X NO CAM |
Carlsmed, Inc | 11/15/2024 | ODP |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter |
Creagh Medical Ltd. dba Surmodics, Inc. |
11/15/2024 | LIT |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator |
Dent4You AG | 11/15/2024 | ELW |
| K233081 | NUVENTUS NV.C™ Dental Implant System |
Infinitum Eta Ltd. | 11/15/2024 | DZE |
| K242130 | Koios DS | Koios Medical, Inc. | 11/15/2024 | POK |
| K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator |
LivsMed Inc. | 11/15/2024 | GEI |
| K242062 | 1CMR Pro | Mycardium AI Limited | 11/15/2024 | LLZ |
| K242800 | The 5000 Compact Series Ultrasound Systems |
Philips Ultrasound LLC | 11/15/2024 | IYN |
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) |
Shenzhen VitaVitro Biotech Co., Ltd. |
11/15/2024 | MQE |
| K243299 | ACUSON Redwood Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
11/15/2024 | IYN |
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter With EZ Steer Technology And Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter With EZ Steer Technology And Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) |
Surgical Instrument Service and Savings Inc.(dba Medline ReN |
11/15/2024 | NLH |
| K243285 | TMINI Miniature Robotic System | Think Surgical, Inc. | 11/15/2024 | OLO |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing Device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) |
Tianjin Huahong Technology Co., Ltd. |
11/15/2024 | QRL |
| K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 11/15/2024 | SDJ |
| K241070 | Gelsoft™ Plus Vascular Prostheses |
Vascutek Ltd. | 11/15/2024 | DSY |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | 11/15/2024 | MQB |
| K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage |
Vuno Inc. | 11/15/2024 | QFM |
| K242079 | Arthrex Elbow Fracture Plating System |
Arthrex Inc. | 11/14/2024 | HRS |
| K241339 | Besmed Bacterial Filter And HMEF |
Besmed Health Business Corp |
11/14/2024 | CAH |
| K242342 | Fetal EchoScan | BrightHeart | 11/14/2024 | POK |
| K241397 | Hinscope | Hinlab SAS | 11/14/2024 | MSX |
| K242598 | DEFINE System (AG612444A) | InMode Ltd. | 11/14/2024 | PBX |
| K242814 | Tandry Q-Locking Plate System | Microware Precision Co., Ltd. |
11/14/2024 | HRS |
| K242440 | Intense Pulsed Light Treatment System (LK-PT) |
Nanjing Bestview Laser S&T Co., Ltd. |
11/14/2024 | ONF |
| K242940 | Xrecovery (XR-001) | SHENZHEN XINRUN ELECTRIC APPLIANCES CO LTD |
11/14/2024 | IRP |
| K242436 | Proximal Humerus Fixation System |
Skeletal Dynamics, Inc. | 11/14/2024 | HRS |
| K241930 | Veincare | Wontech Co., Ltd. | 11/14/2024 | GEX |
| K243273 | CeQur Simplicity™ On-Demand Insulin Delivery System |
CeQur SA | 11/13/2024 | OPP |
| K242764 | MediRod Pedicle Screw System | CMF Medicon Surgical Inc | 11/13/2024 | NKB |
| K241135 | RESPOND(R) Ventilator | CorVent Medical, Inc. | 11/13/2024 | CBK |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) |
Guangdong JINME Medical Technology Co., Ltd. |
11/13/2024 | EFB |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription Use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC Use) (Bordered, Bordered Lite, Non-Bordered, And Transfer) |
Huizhou Foryou Medical Devices Co., Ltd. |
11/13/2024 | FRO |
| K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) |
Hunan Vsmile Biotechnology Co., Ltd. |
11/13/2024 | EIH |
| K211498 | Nonin OTC Pulse Oximeter Model 3250 |
Nonin Medical Inc. | 11/13/2024 | OLK |
| K241981 | Change Healthcare Stratus Imaging PACS |
Change Healthcare Canada Company |
11/12/2024 | LLZ |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) |
Coloplast Corp. | 11/12/2024 | FED |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces Including Straight And Geared Angle Handpieces And Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) |
Foshan SOCO Precision Instrument Co.,Ltd. |
11/12/2024 | EFB |
| K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) |
LifeSignals, Inc. | 11/12/2024 | DRG |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) |
Medtronic MiniMed | 11/12/2024 | NDC |
| K242420 | Pnovus 21 Microcatheter | phenox Ltd | 11/12/2024 | DQO |
| K240771 | PRORAD X-Ray Flat Panel Detector With DROC |
Prognosys Medical Systems Private Limited |
11/12/2024 | MQB |
| K242430 | Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) |
Soul Mobility | 11/12/2024 | ITI |
| K242502 | Aurelia Surgical Mask ASTM Level-3 (2130) |
Supermax Healthcare Canada – Supermax Medical |
11/12/2024 | FXX |
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask |
Vyaire Medical, Inc. | 11/12/2024 | CCK |
| K242791 | Electric Wheelchair (KR-8807) | Zhejiang Kairui Medical Device Co., Ltd. |
11/12/2024 | ITI |
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) |
Straumann USA, LLC | 11/11/2024 | NHA |
| K243233 | Esolution® Esophageal Retractor |
S4 Medical Corp. | 11/09/2024 | QXU |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette |
Hangzhou Clongene Biotech Co.,Ltd. |
11/08/2024 | NGL |
| K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt Ltd |
11/08/2024 | MLO |
| K241802 | Device 300397 Putty | Geistlich Pharma AG | 11/08/2024 | MQV |
| K242286 | Superflow Prime Treatment System (ASP-1M) |
Guangzhou Aimira Innovation Technology Co, Ltd. |
11/08/2024 | GEI |
| K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB |
11/08/2024 | KPS |
| K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 11/08/2024 | GEI |
| K240417 | ProFound Detection (V4.0) | iCAD, Inc. | 11/08/2024 | QDQ |
| K242382 | Décolite LED Device | ISMART Developments Ltd | 11/08/2024 | OHS |
| K243004 | Xpine Spinal Fixation System | Jeil Medical Corporation | 11/08/2024 | NKB |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies |
11/08/2024 | PLF |
| K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) |
Pulnovo Medical (Wuxi) Co., Ltd |
11/08/2024 | DYB |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent |
Rizhao HuGe Biomaterials Company, Ltd. |
11/08/2024 | KLE |
| K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
11/08/2024 | IYN |
| K241342 | Hair Growth Comb (SZ-23,SZ-23A) |
Shenzhen Nuon Medical Equipment Co., Ltd |
11/08/2024 | OAP |
| K240510 | Microdacyn Hydrogel | Sonoma Pharmaceuticals, Inc. |
11/08/2024 | FRO |
| K243075 | Defendo Single Use Cleaning Adapter For Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) |
Steris Corporation | 11/08/2024 | ODC |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) |
Waldemar Link GmbH & Co. KG |
11/08/2024 | LPH |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel |
BioFire Diagnostics, LLC | 11/07/2024 | PCH |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) |
Aspen Imaging Healthcare Inc |
11/07/2024 | MQB |
| K212425 | MicroTrend System | ExoStat Medical, Inc. | 11/07/2024 | |
| K241468 | Vertiwedge® Intraosseous System |
Foundation Surgical Group, Inc. |
11/07/2024 | MQP |
| K240712 | Icobrain Aria | icometrix NV | 11/07/2024 | QBS |
| K240429 | Trilogy Tissue Marker | INRAD Inc. | 11/07/2024 | NEU |
| K242373 | Mako Shoulder Application (1.0) |
MAKO Surgical Corp. | 11/07/2024 | OLO |
| K241719 | NeuroICH | Neurocareai Inc. | 11/07/2024 | QAS |
| K240415 | Newclip Patient-matched Instrumentation Non Sterile PSI |
Newclip Technics | 11/07/2024 | PBF |
| K242379 | LL Implant System | Ossvis Co., Ltd. | 11/07/2024 | DZE |
| K241872 | Remanufactured EndoWrist ProGrasp Forceps (420093) |
Rebotix | 11/07/2024 | QSM |
| K242595 | Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) |
Shenzhen Greatro Electronic Technology Co., Ltd |
11/07/2024 | OHT |
| K242702 | VioSeal | SPIDENT CO., LTD. | 11/07/2024 | KIF |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI |
Stryker Spine | 11/07/2024 | KWQ |
| K241853 | Titaniuim Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve |
Varian Medical Systems, Inc. |
11/07/2024 | JAQ |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System |
ZSFab | 11/07/2024 | ODP |
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel Plus (BIOFIRE Pneumonia Panel Plus) |
BioFire Diagnostics, LLC (bioMerieux) |
11/06/2024 | QDS |
| K240997 | Hi-Torque Command 14 ST Guide Wire And Hi-Torque Command 14 MT Guide Wire |
Abbott Medical | 11/06/2024 | DQX |
| K240450 | Citrepore™ | Acuitive Technologies, Inc. |
11/06/2024 | MQV |
| K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH |
11/06/2024 | GCJ |
| K242261 | Accelx Implant System | Biotech Dental LLC | 11/06/2024 | DZE |
| K242412 | Agility Symmetric™ Total Knee System |
Medisurge, LLC | 11/06/2024 | MBH |
| K242803 | Compound W Skin Tag Remover | Medtech Products Inc. | 11/06/2024 | GEH |
| K242719 | ELEXIR 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. | 11/06/2024 | PCC |
| K242039 | Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) |
Shenzhen Ulike Smart Electronics Co.,Ltd. |
11/06/2024 | OHT |
| K243106 | CarboClear® Hybrid Pedicle Screw System |
Carbofix Orthopedics Ltd. |
11/05/2024 | NKB |
| K242947 | FreedomFlow™ Orbital Circumferential Atherectomy System |
Cardio Flow, Inc. | 11/05/2024 | MCW |
| K240624 | InfuLife | First Medical Source, LLC |
11/05/2024 | MEB |
| K242664 | Gentleheel® Adult Incision Device |
GRI-Alleset, Inc. | 11/05/2024 | FMK |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) |
Imaxeon Pty Ltd | 11/05/2024 | IZQ |
| K231287 | POTENZA | Jeisys Medical Inc. | 11/05/2024 | GEI |
| K243015 | Skyway Anterior Cervical Plate System |
Kyocera Medical Technologies, Inc. |
11/05/2024 | KWQ |
| K241484 | Atlas™ Humeral Nail System | Orthopedic Designs North America, Inc. (ODI-NA) |
11/05/2024 | HSB |
| K242345 | Delphi Stimulator | QuantalX Neuroscience | 11/05/2024 | GWF |
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) |
Shenzhen Kentro Medical Electronics Co., Ltd. |
11/05/2024 | NUH |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) |
TeraRecon,Inc. | 11/05/2024 | QIH |
| K242340 | DESS Dental Smart Solutions | Terrats Medical SL | 11/05/2024 | NHA |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel |
Bionime Corporation | 11/04/2024 | NBW |
| K242567 | Muscle And Nerve Stimulator TENS & EMS (TP2208), Muscle And Nerve Stimulator TENS & EMS (TP2208C) |
Changsha Anxiang Medical Technology Co., Ltd. |
11/04/2024 | NUH |
| K240438 | CDB Hospital ® Sterilization Wrap (70 Gsm); CDB Hospital ® Sterilization Wrap (44 Gsm) |
Comercializadora Brever | 11/04/2024 | FRG |
| K242709 | JLK-PWI | JLK, Inc. | 11/04/2024 | LLZ |
| K240512 | Tixel I (TXLI0001) | Novoxel Ltd. | 11/04/2024 | ORZ |
| K243061 | SonoStik Guide Wire Introducer | SonoStik, LLC | 11/04/2024 | DYB |
| K242195 | Gemini Cervical Fusion Cage System |
ZheJiang Decans Medical Devices Co., Ltd. |
11/04/2024 | ODP |
| K240388 | Osteotomy Truss System (OTS) | 4WEB Medical, Inc. | 11/01/2024 | HRS |
| K242393 | Acuity 181™ (tisilfocon A) And Acuity 181™ (tisilfocon A) With Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses |
Acuity Polymers, Inc. | 11/01/2024 | HQD |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set |
Applied Medical Technology, Inc. |
11/01/2024 | KOB |
| K242076 | VersaCross™ RF Wire | Baylis Medical Company | 11/01/2024 | DXF |
| K242320 | BD Vacutainer® One Use Holder | Becton Dickinson and Company |
11/01/2024 | JKA |
| K240366 | EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
11/01/2024 | DRF |
| K240881 | Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) |
Covidien (Part of Medtronic) |
11/01/2024 | GAG |
| K242665 | DePuy ATTUNE™ Total Knee System |
DePuy Orthopedics Inc | 11/01/2024 | OIY |
| K242591 | XERO-alpha | DRTECH Corporation | 11/01/2024 | EHD |
| K243091 | Over-tube (TR-1108A) | Fujifilm Corporation | 11/01/2024 | FED |
| K242311 | EXPERT - Flexible Joint Fixation System |
GM dos Reis Industria e Comercio Ltda. |
11/01/2024 | HTN |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit |
Medtronic, Inc. | 11/01/2024 | DQK |
| K241646 | ORTIV (ORTIV-BL, ORTIV-WH) | MVITRO CO., LTD. | 11/01/2024 | GEX |
| K242452 | Monkey Bars Pin To Bar External Fixation System |
Paragon 28, Inc. | 11/01/2024 | KTT |
| K243217 | Legend X Desktop System | Pollogen Ltd. | 11/01/2024 | GEI |
| K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) |
Quanta Dialysis Technologies Ltd |
11/01/2024 | ONW |
| K241068 | Udr 780i | Shanghai United Imaging Healthcare Co., Ltd. |
11/01/2024 | KPR |
| K242620 | Breo Laser Hair Growth Comb (Scalp 3L) |
Shenzhen Breo Technology Co., Ltd. |
11/01/2024 | OAP |
| K243381 | Total Wrist Arthroplasty System (TWA) |
Skeletal Dynamics Inc | 11/01/2024 | JWJ |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea Pack) |
Spident Co., Ltd. | 11/01/2024 | KLE |
| K241999 | Prophecy Surgical Planning System |
Wright Medical Technology, Inc (Stryker) |
11/01/2024 | HSN |
| K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports And PowerPort™ ClearVUE™ Slim Implantable Ports |
Bard Access Systems, Inc. |
10/31/2024 | LJT |
| K240455 | BD Vacutainer® Citrate Blood Collection Tubes |
Becton Dickinson and Company |
10/31/2024 | GIM |
| K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo |
Bionova Medical, Inc. | 10/31/2024 | FRO |
| K242399 | Bonebridge Osteosynthesis Plating System |
Bonebridge AG | 10/31/2024 | HRS |
| K241223 | Erad PACS | eRAD, Inc. | 10/31/2024 | LLZ |
| K240383 | Highness Implant System | highness Co., Ltd. | 10/31/2024 | DZE |
| K242623 | Disposable Blood Pressure Cuff; Reusable Blood Pressure Cuff |
Shenzhen Medke Technology Co., Ltd. |
10/31/2024 | DXQ |
| K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
10/31/2024 | CAD |
| K240653 | SmartCardia 7L Platform (MCT) | SmartCardia SA | 10/31/2024 | QYX |
| K240333 | Wearable Digital Thermometer (T31) |
Guangdong Genial Technology CO., Ltd. |
10/30/2024 | FLL |
| K241902 | Edison System | HistoSonics, Inc. | 10/30/2024 | QGM |
| K240847 | MedicCO2LON (MedicCO2LON) | IDE Vision Ltd | 10/30/2024 | FCX |
| K240177 | Zio AT® Device (A100A1001) | iRhythm Technologies, Inc. |
10/30/2024 | DSI |
| K240560 | ZENEX Implant System_Long | Izenimplant Co., Ltd. | 10/30/2024 | DZE |
| K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) |
Lagis Enterprise Co., Ltd. |
10/30/2024 | GCJ |
| K240670 | DRI Ecstasy Plus Assay | Microgenics Corporation | 10/30/2024 | DKZ |
| K241533 | NeurAxis IB-Stim (01-1020) | NeurAxis | 10/30/2024 | QHH |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. |
10/30/2024 | FMK |
| K241108 | RemedyLogic AI MRI Lumbar Spine Reader |
Remedy Logic Inc. | 10/30/2024 | QIH |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family |
Siemens Medical Solutions USA, Inc. |
10/30/2024 | KPS |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) |
Smith & Nephew, Inc. | 10/30/2024 | HSX |
| K242271 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. |
10/30/2024 | SBF |
| K243157 | AtriCure Cryoice BOX (ACM) | AtriCure, Inc. | 10/29/2024 | GXH |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System |
DeGen Medical | 10/29/2024 | OVD |
| K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) |
DEHAS Medical Systems GmbH |
10/29/2024 | CBP |
| K243095 | Mammotome AutoCore™ Single Insertion Core Biopsy System |
Devicor Medical Products, Inc. |
10/29/2024 | KNW |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) |
Hunan Vathin Medical Instrument Co.Ltd |
10/29/2024 | EOQ |
| K241189 | Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) |
JiaXing XiaoXiang Medical Equipment Technology Co., Ltd |
10/29/2024 | ITI |
| K243080 | Riptide Aspiration System | Micro Therapeutics Inc. d/b/a ev3 Neurovascular |
10/29/2024 | NRY |
| K243126 | TRACHEOBRONXANE™ DUMON® | Novatech SA | 10/29/2024 | NWA |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel |
QIAGEN GmbH | 10/29/2024 | PLO |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor |
Riverpoint Medical | 10/29/2024 | MBI |
| K240175 | Tigon Medical Fractures, Instability, And Reconstruction (FIRE) |
Tigon Medical | 10/29/2024 | HWC |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) |
Varian Medical Systems | 10/29/2024 | JAQ |
| K243247 | Persona The Personalized Knee System |
Zimmer, Inc. | 10/29/2024 | MBH |
| K243137 | Curiteva Porous PEEK Laminoplasty System |
Curiteva, Inc. | 10/28/2024 | NQW |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) |
Ethicon Endo-Surgery, LLC |
10/28/2024 | GDW |
| K240303 | MetaLite DX Digital Pathology Software |
JelloX Biotech Inc. | 10/28/2024 | QKQ |
| K241992 | Catalyft™ LS Expandable Interbody System |
Medtronic Sofamor Danek USA, Inc. |
10/28/2024 | OVD |
| K242622 | Sterile Lancets For Single Use | Ningbo Caremed Medical Products Co., Ltd. |
10/28/2024 | QRK |
| K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) |
Shenzhen Aozemei Technology Co. Ltd |
10/28/2024 | OHS |
| K242350 | Spinal Alignment Solutions Pelvic Incidence (PI) Rod System |
Spinal Alignment Solutions, Inc. |
10/28/2024 | NKB |
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 10/25/2024 | OYK |
| K243174 | Cadence Ankle PSI System | 3D Systems, Inc. | 10/25/2024 | OYK |
| K241185 | CORGRIP* SR NG/NI Tube Retention System |
Avanos Medical, Inc. | 10/25/2024 | KNT |
| K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | 10/25/2024 | LOX |
| K240918 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens With UV Blocking For Myopia And Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens With UV Blocking For Astigmatism |
Bruno Vision Care, LLC | 10/25/2024 | LPL |
| K243070 | Xpert® SA Nasal Complete | Cepheid® | 10/25/2024 | NQX |
| K240269 | Nitrile Powder Free Examination Gloves Biodegradable (Green) |
Comfort Rubber Gloves Industries Sdn. Bhd. |
10/25/2024 | LZA |
| K242625 | Freeze Point & Private Label Versions |
CryoConcepts LP | 10/25/2024 | GEH |
| K240223 | FMT Disposable And Autoclavable Temperature Probes |
Metko Medikal ve Tibbi Cihazlar Dis Ticaret Limited Sirketi |
10/25/2024 | FLL |
| K242215 | Neurophet AQUA (V3.1) | Neurophet, Inc. | 10/25/2024 | QIH |
| K242397 | LYNX Photocoagulator | Norlase Aps | 10/25/2024 | HQF |
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle |
OcuJect, LLC | 10/25/2024 | QNS |
| K242984 | BKS Revision System | Ortho Development Corp. | 10/25/2024 | JWH |
| K242353 | QIAstat-Dx Respiratory Panel Mini |
Qiagen GmbH | 10/25/2024 | QOF |
| K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616W |
Shenzhen Beacon Display Technology Co.,Ltd. |
10/25/2024 | PGY |
| K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 And YM504) |
Shenzhen Yimi Life Technology Co., Ltd. |
10/25/2024 | DQA |
| K243189 | TumorSight Viz | SimBioSys, Inc. | 10/25/2024 | QIH |
| K243030 | Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) |
Ulike Co., Ltd. | 10/25/2024 | OHT |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) |
VATECH Co., Ltd | 10/25/2024 | MUH |
| K242458 | ArgenZ MTZ | Argen Corporation | 10/24/2024 | EIH |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | 10/24/2024 | EIH |
| K242560 | Manual Wheelchair (SYIV100-CA9221) |
Foshan Shunkangda Medical Tech Co., Ltd. |
10/24/2024 | IOR |
| K242086 | MagDI System (MAG-01, DS-01) | GT Metabolic Solutions, Inc. |
10/24/2024 | SAH |
| K240391 | MUTARS® Femoral Stem Cemented 160 Mm And 200 Mm |
Implantcast, GmbH | 10/24/2024 | LZO |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | 10/24/2024 | EBI |
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) |
Medency S.r.l. | 10/24/2024 | GEX |
| K242034 | Duet External Drainage And Monitoring System (EDMS) |
Medtronic Neurosurgery | 10/24/2024 | PCB |
| K242512 | ROCC Console | Philips Medical Systems Nederland B.V. |
10/24/2024 | LLZ |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E And TelliBP01) |
Shenzhen Urion Technology Co.,Ltd. |
10/24/2024 | DXN |
| K241554 | Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) |
Telefield Medical Imaging (Shenzhen) Limited |
10/24/2024 | IYN |
| K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. |
10/23/2024 | MUJ |
| K241324 | LifeScale Gram Negative Kit (LSGN) With The LifeScale AST System |
Affinity Biosensors, LLC | 10/23/2024 | SAN |
| K241753 | Immediate Molar Implants | Biomet 3i, LLC | 10/23/2024 | DZE |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); |
DRTECH Corporation | 10/23/2024 | KPR |
| K241988 | ProSeal™ Closed System Bag Access |
Epic Medical Pte. Ltd. | 10/23/2024 | ONB |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) |
Guangdong OptoMedic Technologies, Inc. |
10/23/2024 | GCJ |
| K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited |
10/23/2024 | CDZ |
| K242829 | BluEX Lumbar Expandable Cage System |
L&K BIOMED Co., Ltd. | 10/23/2024 | MAX |
| K243007 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. |
10/23/2024 | NKB |
| K243012 | MIM – Symphony HDR Fusion | MIM Software Inc. | 10/23/2024 | LLZ |
| K234060 | KIDNEYvault Portable Renal Perfusion System |
Paragonix Technologies | 10/23/2024 | KDN |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) |
Scivita Medical Technology Co., Ltd. |
10/23/2024 | EOQ |
| K242589 | Scarlet® AL-T | Spineart SA | 10/23/2024 | MAX |
| K242995 | OIC Small / Mini Fragment Plate System |
The Orthopaedic Implant Company |
10/23/2024 | HRS |
| K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) |
TSK Laboratory International Japan KK |
10/23/2024 | QYM |
| K241876 | Vitesse (5.0) | Varian Medical Systems | 10/23/2024 | MUJ |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2) |
Weifang Mingliang Electronics CO., LTD. |
10/23/2024 | GEX |
| K242250 | PuraStat | 3-D Matrix Europe SAS | 10/22/2024 | QAU |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) |
AViTA Corporation | 10/22/2024 | DXN |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter |
BrosMed Medical Co., Ltd. |
10/22/2024 | PNO |
| K240506 | KARL STORZ Holders | KARL STORZ Endoscopy America, Inc |
10/22/2024 | OCV |
| K243209 | Nordicmediva | NordicNeurolab AS | 10/22/2024 | LLZ |
| K241532 | Flexible Video-Choledo-Cysto-Ureterosco pe System (PL-2100) |
Shanghai SeeGen Photoelectric Technology Co., Ltd. |
10/22/2024 | FET |
| K241572 | ARTIS Icono (VE40A) (floor); ARTIS Icono (VE40A) (biplane); ARTIS Icono (VE40A) (ceiling); ARTIS Pheno (VE40A) |
Siemens Medical Solutions USA, Inc |
10/22/2024 | OWB |
| K242099 | Sol-M™ Slip Tip Syringe Without Needle, Sol-M™ Eccentric Tip Syringe Without Needle |
Sol-Millennium Medical Inc. |
10/22/2024 | FMF |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses |
Tianjin MasterVision Technology Co., Ltd. |
10/22/2024 | HQD |
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) |
Stryker Sustainability Solutions |
10/22/2024 | NLF |
| K242058 | Digital Prism Correction Feature (DPCF) |
Apple Inc. | 10/21/2024 | SCW |
| K242554 | Arthrex VAL And VAL KreuLock™ Compression Screw System |
Arthrex, Inc. | 10/21/2024 | HRS |
| K240029 | Zio AT® Device (A100A1001) | iRhythm Technologies, Inc. |
10/21/2024 | QYX |
| K242157 | Anovo Surgical System (Model 6Ne) |
Momentis Surgical Ltd. | 10/21/2024 | QNM |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems |
Smith & Nephew, Inc. | 10/21/2024 | JDI |
| K222740 | Venus Ag 120, 160, 200 2x2 Inch, Venus Ag 120, 160, 200 4x4 Inch, Venus Ag 120, 160, 200 4x5 Inch, Venus Ag 120, 160, 200 6x6 Inch,venus Ag 120, 160, 200 1x18 Inch |
Speciality Fibres and Materials Ltd. |
10/21/2024 | FRO |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation |
Stryker Instruments | 10/21/2024 | GEI |
| K241170 | Dynamic TiBase; TRI Screws | Talladium España, SL | 10/21/2024 | NHA |
| K241959 | 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) |
3M Company | 10/18/2024 | FRC |
| K233378 | ABCcolla® Collagen ADM Scaffold |
ACRO Biomedical Co., Ltd. |
10/18/2024 | KGN |
| K242837 | BriefCase-Triage | Aidoc Medical, Ltd. | 10/18/2024 | QAS |
| K242372 | Mg OSTEOREVIVE™, Mg OSTEOCRETE™ |
Bone Solutions, Inc | 10/18/2024 | MQV |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) |
Boston Scientific Corp. | 10/18/2024 | GEH |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) |
Coloplast Corp | 10/18/2024 | PAH |
| K232994 | Vittra APS Unique Flow | Dentscare LTDA | 10/18/2024 | EBF |
| K240725 | PreXolid CAD/CAM Abutments | Eclectic Co., Ltd. | 10/18/2024 | NHA |
| K241131 | Edelweiss CAD/CAM T-BLOCK; Edelweiss CAD/CAM C-BLOCK; Edelweiss CAD/CAM I-block; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM I-block |
Edelweiss Dentistry Products GmbH |
10/18/2024 | EBF |
| K242132 | FREDDO | Fabinject lndustria e Comercio lmportacao e Exportacao Ltda |
10/18/2024 | GEX |
| K242813 | Materialise Shoulder System™, Materialise Shoulder Guide And Models, SurgiCase Shoulder Planner |
Materialise N.V. | 10/18/2024 | QHE |
| K241490 | Contour+ (MVision AI Segmentation) |
MVision AI Oy | 10/18/2024 | QKB |
| K242864 | ROSA® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS |
10/18/2024 | OLO |
| K240226 | Pixie Skin Tag | Oystershell NV | 10/18/2024 | ORE |
| K242879 | Ds Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. |
10/18/2024 | MOS |
| K243033 | Ds Wrist Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. |
10/18/2024 | MOS |
| K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies Ltd. |
10/18/2024 | JAK |
| K242868 | Kinos Total Ankle System | restor3d | 10/18/2024 | HSN |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture |
SafePath Medical, Inc. | 10/18/2024 | GAP |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask |
Sleepnet Corporation | 10/18/2024 | BZD |
| K242828 | Corplex P/ Theracor P/ Allacor P |
StimLabs, LLC | 10/18/2024 | KGN |
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator |
Well-Life Healthcare Limited |
10/18/2024 | NUH |
| K242435 | Dental Barrier And Sleeves | Wellmed Dental Medical Supply Co., Ltd |
10/18/2024 | PEM |
| K240916 | Surgical Face Mask (Tie On/ Ear Loops) |
Xiantao Daoqi Plastic Co., Ltd. |
10/18/2024 | FXX |
| K240160 | EGPS Navigated Instruments | Astura Medical | 10/17/2024 | OLO |
| K242899 | NOVA Minimally Invasive System | BAUI Biotech Co., Ltd. | 10/17/2024 | NKB |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) |
Epitel, Inc | 10/17/2024 | OMB |
| K240218 | Electric Breast Pump (F5055) | Fimilla (Shanghai) maternity & baby Articles Co., Ltd |
10/17/2024 | HGX |
| K241242 | SIGNA MAGNUS | GE Medical Systems, LLC | 10/17/2024 | LNH |
| K240321 | MP Pin Flat Without Thread (36BMP000020/MP20) |
Hager & Meisinger GmbH | 10/17/2024 | DZL |
| K241267 | Hidroxa SE30 | Hidroxa Medical AB | 10/17/2024 | EGJ |
| K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences | 10/17/2024 | FRO |
| K241337 | Electrically Powered Wheelchair (HP202) |
Kunshan Hi-Fortune Health Products Co., Ltd |
10/17/2024 | ITI |
| K242809 | Ascent Cardiorespiratory Diagnostic Software |
Medical Graphics Corporation |
10/17/2024 | BTY |
| K240711 | Zipline Access Catheter | Perfuze Ltd. | 10/17/2024 | QJP |
| K242197 | IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) |
Shenzhen Huaruibo Electric Appliances Co., Ltd |
10/17/2024 | OHT |
| K240468 | Alkaline Phosphatase | Abbott Laboratories Diagnostics Division |
10/16/2024 | CJE |
| K240849 | Ambu® Ascope™ 5 Cysto HD (Standard Deflection); Ambu® Ascope™ 5 Cysto HD (Reverse Deflection); Ambu® Abox™ 2 |
Ambu A/S | 10/16/2024 | FAJ |
| K241481 | Xvision Spine System | Augmedics Ltd. | 10/16/2024 | SBF |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set |
Cerenovus Inc. | 10/16/2024 | NRY |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter |
Cerenovus, Inc. | 10/16/2024 | QJP |
| K240114 | UltraEzAir® (UEA1A) | DUALAMS, Inc., dba AirKor |
10/16/2024 | CCT |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm |
Edwards Lifesciences | 10/16/2024 | MUD |
| K242556 | JLK-CTP | JLK, Inc. | 10/16/2024 | LLZ |
| K241632 | Electrically Powered Wheelchair |
Kunshan Hi-Fortune Health Products Co., Ltd |
10/16/2024 | ITI |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0) |
LI Medical Corporation Ltd. |
10/16/2024 | LKF |
| K241613 | Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) |
Shenzhen HBcare Technology Co.,Ltd |
10/16/2024 | DXN |
| K242839 | Safe Secure Sterilization Pouches And Rolls |
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. |
10/16/2024 | FRG |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods And Togas |
Stryker Instruments | 10/16/2024 | FYA |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. |
10/16/2024 | KRD |
| K242784 | Vy Spine™ VyLam™ Laminoplasty System |
Vy Spine, LLC | 10/16/2024 | NQW |
| K242781 | Cvi42 Software Application | Circle Cardiovascular Imaging Inc. |
10/15/2024 | QIH |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) |
Cure Point Therapeutics, Inc. |
10/15/2024 | ILY |
| K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC | 10/15/2024 | EBF |
| K241894 | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath |
Inari Medical, Inc. | 10/15/2024 | QEW |
| K240385 | VINT | Mediimg Corporation | 10/15/2024 | LLZ |
| K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. |
10/15/2024 | LQR |
| K241673 | Denture Base Resin (PN-Denture (Red, White)) |
Shenzhen Piocreat 3D Technology Co., Ltd. |
10/15/2024 | EBF |
| K242795 | Getinge Assured MI Steam Migrating Integrator |
SteriTec Products Mfg. (a Getinge Group Company) |
10/15/2024 | JOJ |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) |
TauTona Group | 10/15/2024 | HIF |
| K242812 | NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) |
NB MEDICAL COMPANY LIMITED |
10/12/2024 | LZA |
| K242035 | Accure Laser System | Accure Acne, Inc | 10/11/2024 | GEX |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) |
AIROS Medical, Inc. | 10/11/2024 | JOW |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) |
Anhui DEEPBLUE Medical Technology Co. LTD. |
10/11/2024 | LCX |
| K242095 | Access Toxo IgM II | Beckman Coulter Inc. | 10/11/2024 | LGD |
| K234110 | Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited |
10/11/2024 | DQA |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) |
Centerline Biomedical, Inc. |
10/11/2024 | DQK |
| K232565 | UriSponge™ | Copan Italia S.p.A. | 10/11/2024 | JSM |
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) |
Dongguan Boyuan Intelligent Technology Co., Ltd. |
10/11/2024 | OHS |
| K240472 | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd |
10/11/2024 | OAP |
| K242779 | Hood (DH-083ST) | Fujifilm Corporation | 10/11/2024 | FDS |
| K241163 | SPECTRALIS With Flex Module | Heidelberg Engineering GmbH |
10/11/2024 | OBO |
| K240143 | JDZygoma Dental Implants | JDentalCare Srl | 10/11/2024 | DZE |
| K240501 | Spark™ Clear Aligner System | Ormco Corporation | 10/11/2024 | NXC |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | 10/11/2024 | LPH |
| K240797 | PPH Saliva Collection Kit | Permantis Public Health | 10/11/2024 | QBD |
| K233265 | Monotime And Optime R | Peters Surgical | 10/11/2024 | GAM |
| K241153 | Progressive Orthodontics App | Progressive Aligners Inc. |
10/11/2024 | PNN |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) |
Qpix Solutions Inc | 10/11/2024 | MUH |
| K232779 | QUEX ED; QUEX S | QX World Ltd | 10/11/2024 | OMC |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
10/11/2024 | IYN |
| K241569 | Syngo Application Software | Siemens Medical Solutions USA, Inc |
10/11/2024 | LLZ |
| K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter |
Sterilmed, Inc. | 10/11/2024 | NLH |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc For OLYMPUS EUS (00711900) |
STERIS Corporation | 10/11/2024 | ODC |
| K242387 | Mobility Scooter (N3473) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
10/11/2024 | INI |
| K240262 | BTI Interna 3.0 Dental Implant System UnicCa® |
B.T.I. Biotechnology Institute, S.L. |
10/10/2024 | DZE |
| K242389 | EyeGility™ Inserter For Preloaded Envista IOLs |
Bausch & Lomb Incorporated |
10/10/2024 | MSS |
| K241951 | Lasya-Trinity | Bluecore Company Co., Ltd. |
10/10/2024 | GEX |
| K233947 | KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System |
CTL Medical Corporation | 10/10/2024 | MAX |
| K241735 | ProSeal™ In Line Pump Set (423850) |
Epic Medical Pte. Ltd. | 10/10/2024 | ONB |
| K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System |
Greens Surgicals Pvt. Ltd. |
10/10/2024 | NKB |
| K241430 | EchoMeasure | iCardio.ai | 10/10/2024 | QIH |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT |
Quanta System S.p.A. | 10/10/2024 | GEX |
| K242515 | Udr 380i Pro | Shanghai United Imaging Healthcare Co.,Ltd. |
10/10/2024 | IZL |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) |
Siemens Healthcare Diagnostics Products GmbH |
10/10/2024 | QLU |
| K241491 | Blueprint Patient-Specific Instrumentation; Shoulder Id Primary Reversed Glenoid |
Stryker Corporation (Tornier, S.A.S.) |
10/10/2024 | PHX |
| K240992 | Emvfit (MVF-10M) | WEERO Co.,Ltd. | 10/10/2024 | IPF |
| K242400 | Dental Porcelain Powder | Yilink (Tianjin) Biotechnology Co., Ltd. |
10/10/2024 | EIH |
| K240786 | AutoChamber | HeartLung Corporation | 10/10/2024 | QIH |
| K240848 | Ambu® Ascope™ 5 Cysto HD (Standard Deflection); Ambu® Ascope™ 5 Cysto HD (Reverse Deflection); Ambu® Aview™ 2 Advance |
Ambu A/S | 10/10/2024 | FAJ |
| K240181 | Clavicle And Scapula System | Auxein Medical Pvt. Ltd | 10/09/2024 | HRS |
| K241477 | Aprevo® Anterior Lumbar Interbody Fusion Device With Interfixation |
Carlsmed, Inc. | 10/09/2024 | OVD |
| K242029 | TRAP EASY | HS Hospital Service SPA | 10/09/2024 | KNW |
| K241837 | Limbus Contour | Limbus AI Inc. | 10/09/2024 | QKB |
| K231948 | MEDIYAG | Medicreations LLC | 10/09/2024 | GEX |
| K242691 | OsteoCentric Technologies Cannulated Fasteners And Nuts |
OsteoCentric Technologies |
10/09/2024 | HWC |
| K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) |
Shanghai Care Us Medical Product Co., Ltd. |
10/09/2024 | LRX |
| K241355 | SER Pen Carain MicroSystem (MP1209SP) |
Su-Ko Technologies LLC | 10/09/2024 | QAI |
| K242021 | The Sensititre 20 - 24 Hour Haemophilus Influenzae/streptococcus Pneumoniae (HP) MIC Or Breakpoint Susceptibility System With Meropenem In The Dilution Range Of 0.015 - 32 Ug/ml. |
Thermo Fisher Scientific | 10/09/2024 | JWY |
| K241485 | TruAbutment DS; TruBase | TruAbutment Inc. | 10/09/2024 | NHA |
| K240991 | Emvfit (MVF-10M) | Weero Co., Ltd. | 10/09/2024 | PBX |
| K240167 | Single-use Ureteral Access Sheath |
Hunan Vathin Medical Instrument Co., Ltd. |
10/08/2024 | FED |
| K240379 | TROJAN SIS Synthetic Latex Condom With Silicone Lubricant |
Church & Dwight Co., Inc. |
10/08/2024 | MOL |
| K242826 | ProLift Wedge Expandable Spacer System |
Life Spine, Inc. | 10/08/2024 | MAX |
| K242391 | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens |
LUCENS TECHNOLOGY Co., Ltd. |
10/08/2024 | LPL |
| K242014 | Jet Flow Bulk | META Biomed Co., Ltd. | 10/08/2024 | EBF |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System |
Sejoy Biomedical Co., Ltd |
10/08/2024 | NBW |
| K241446 | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) |
Sichuan QianIi-beoka Medical TechnoIogy lnc. |
10/08/2024 | IRP |
| K241756 | Nerivio; NerivioInfinity | Theranica Bio-Electronics Ltd |
10/08/2024 | QGT |
| K242267 | Gemini Medical Cage System | ZheJiang Decans Medical Devices Co., Ltd. |
10/08/2024 | MAX |
| K240563 | Power Wheelchair (JJW-6001) | ZheJiang J&J Mobility Co., Ltd |
10/08/2024 | ITI |
| K240843 | GENESIS (MS-P02-GEN) | Climbing Steps Inc. | 10/07/2024 | ILK |
| K242693 | DEKA Infusion System, DEKA Administration Set |
DEKA Research and Development Corporation |
10/07/2024 | LDR |
| K242084 | EMPHASYS Acetabular Shell With RapiTite HA |
DePuy Ireland UC | 10/07/2024 | LPH |
| K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) |
Epic Medical Pte. Ltd. | 10/07/2024 | MEB |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription Use),luofucon® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC Use) |
Huizhou Foryou Medical Devices Co., Ltd. |
10/07/2024 | FRO |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) |
Olympus Medical Systems Corporation |
10/07/2024 | OCX |
| K242746 | OvertureTi Knee Resurfacing SystemTM |
Overture Orthopaedics | 10/07/2024 | HSX |
| K240980 | EPIQ Series Diagnostic Ultrasound System |
Philips Ultrasound LLC | 10/07/2024 | IYN |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) |
PRIMED Medical Products Inc. |
10/07/2024 | FRG |
| K242457 | EARP Interbody System | Retropsoas Technologies, LLC |
10/07/2024 | MAX |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 10/07/2024 | LPH |
| K241029 | SpineUs™ System | Verdure Imaging | 10/07/2024 | IYO |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System |
Stryker GmbH | 10/06/2024 | HRS |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models |
Actuated Medical, Inc. | 10/04/2024 | FDF |
