IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) |
Olympus Medical Systems Corp. |
02/22/2026 | FDT |
| K251692 | Advanced Tissue Resection Device |
Micro-Tech (Nanjing) Co., Ltd. |
02/21/2026 | FDI |
| K253445 | BD Surgiphor™ 1000 Ml Antimicrobial Irrigation System (910120) |
Bd | 02/20/2026 | FQH |
| K252972 | CARTO™ 3 EP Navigation System V8.4 |
Biosense Webster, Inc. | 02/20/2026 | DQK |
| K252500 | CARA System | Cara Medical, Ltd. | 02/20/2026 | OWB |
| K252672 | CaseBio™ Culture W/hsa (CMH5); CaseBio™ Handling W/hsa (WHH5) |
Casebioscience, Inc. | 02/20/2026 | MQL |
| K253653 | Xpert Hemorrhagic Fever | Cepheid | 02/20/2026 | |
| K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) |
Foreo, Inc. | 02/20/2026 | OHS |
| K260181 | LF Process Indicator Tape For Steam Sterilization |
Intertape Polymer Group | 02/20/2026 | JOJ |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | 02/20/2026 | |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 02/20/2026 | HRS |
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. |
02/20/2026 | FMK |
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set |
Point Robotics MedTech, Inc. |
02/20/2026 | OLO |
| K252619 | QSCHECK UISACR | Qstag, Inc. | 02/20/2026 | JFY |
| K251653 | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | 02/20/2026 | OBP |
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. |
02/20/2026 | FAD |
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System |
Acclarent, Inc. | 02/19/2026 | PNZ |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. |
02/19/2026 | MUJ |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use With StealthStation) |
Alphatec Spine, Inc. | 02/19/2026 | OLO |
| K260205 | AS Software Version Asera | AS Software, LLC | 02/19/2026 | LLZ |
| K253687 | Access Anti-hbc Total (C39432) Access Anti-hbc Total Calibrator (C39433) Access Anti-hbc Total QC (C39434) |
Beckman Coulter, Inc. | 02/19/2026 | SEI |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 02/19/2026 | DYB |
| K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe With Needle /Profoject™ Tuberculin Syringe With Needle; Profoject™ Low Dead Space Syringe With Permanent Needle /Profoject™ Tuberculin Syringe With Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe |
CMT Health PTE., Ltd. | 02/19/2026 | QNQ |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) |
Efofex, Inc. | 02/19/2026 | FXX |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 02/19/2026 | MUJ |
| K251903 | Erchonia DPN Laser (Model# EVRL) |
Erchonia Corporation | 02/19/2026 | NHN |
| K253002 | SkinStylus SteriLock MicroSystem (MP1209SL) |
Esthetic Medical, Inc. | 02/19/2026 | QAI |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. |
02/19/2026 | |
| K254018 | Portable Dental X-ray Device (GT-1) |
Guilin Refine Medical Instrument Co., Ltd. |
02/19/2026 | EHD |
| K260218 | LacertaMatrix | Lacerta Life Sciences | 02/19/2026 | KGN |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae |
Medtronic, Inc. | 02/19/2026 | DWF |
| K252733 | ATLAS™ Expandable Osteotomy Wedge System |
MiRus, LLC | 02/19/2026 | PLF |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 02/19/2026 | OLO |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor |
Stryker Leibinger GmbH & Co KG |
02/19/2026 | OLO |
| K253539 | Alere NT-proBNP For Alinity I | Axis-Shield Diagnostics, Ltd. |
02/18/2026 | NBC |
| K252561 | BTL-754FF | BTL Industries, Inc. | 02/18/2026 | GEX |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert |
Howmedica Osteonics Corp., Dba Stryker Orthopaedics |
02/18/2026 | MBH |
| K252098 | PA3X Detachable Safety Sleeve Syringe (with Needle) (SC-23ED / SD-23ED) |
Methyl Co., Ltd. | 02/18/2026 | MEG |
| K252197 | Nobel Biocare S Series Implants |
Nobel Biocare AB | 02/18/2026 | DZE |
| K253643 | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. |
02/18/2026 | INI |
| K260185 | 1688 4K Camera System With Advanced Imaging Modality; 1788 4K Camera System With Advanced Imaging Modality |
Stryker Endoscopy | 02/18/2026 | GCJ |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | 02/17/2026 | MAI |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | 02/17/2026 | MQV |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) |
Centerline Biomedical, Inc. |
02/17/2026 | DQK |
| K250550 | FUJIFILM Endoscope Model EG-S100XT And VS-1000 Display Unit |
Fujifilm Corporation | 02/17/2026 | FDS |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) |
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. |
02/17/2026 | DQA |
| K260149 | Versus™ Catheter (VS110-9NB) | Liquet Medical, Inc. | 02/17/2026 | QEY |
| K253599 | Electric Wheelchair (W-A807, W-A807L) |
Ningbo Shenyu Medical Equipment Co.,Ltd |
02/17/2026 | ITI |
| K252512 | Armada™ 14 NC PTA Catheter | Abbott Medical | 02/13/2026 | LIT |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal |
Alcon Laboratories, Inc. | 02/13/2026 | LPL |
| K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 02/13/2026 | MOF |
| K252891 | MEDRAD MRXperion MR Injection System And MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) |
Bayer Medical Care, Inc. | 02/13/2026 | DXT |
| K252565 | PreOp V3 | Clouds of Care | 02/13/2026 | OLX |
| K243854 | Contour Light (CL-100) | Contour Research, LLC | 02/13/2026 | OLI |
| K251619 | Babyleo TN500 | Drägerwerk AG & Co KGaA | 02/13/2026 | FMZ |
| K252400 | Endomina EZFuse System | Endo Tools Therapeutics S.A. |
02/13/2026 | OCW |
| K252685 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) |
Joytech Healthcare Co. , Ltd. |
02/13/2026 | DXN |
| K251742 | VELO Respiratory Test | Lex Diagnostics Limited | 02/13/2026 | QOF |
| K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) |
02/13/2026 | DXH |
| K253149 | Motion InBra (YM-8801) Wearable Breast Pump |
Medela, LLC | 02/13/2026 | HGX |
| K251928 | CoolCryo - Cryoapplicator For Cardiac Cryoablation (CC01-01); CoolCryo - Control Console For Cardiac Cryoablation With Liquid Nitrogen Reservoir (CC01-21) |
Medinice S.A. | 02/13/2026 | GEH |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. |
02/13/2026 | GXI |
| K254105 | Hive™ Standalone Cervical System And Hive™ C Interbody System |
NanoHive Medical, LLC | 02/13/2026 | ODP |
| K253096 | Chartis Precision Catheter | Pulmonx Corporation | 02/13/2026 | CBI |
| K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. |
02/13/2026 | DXG |
| K253564 | Umi Panvivo (uMI Panvivo); Umi Panvivo (uMI Panvivo S); Umi Panvivo (uMI Panvivo EX); Umi Panvivo (uMI Panvivo ES) |
Shanghai United Imaging Healthcare Co., Ltd. |
02/13/2026 | KPS |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) |
Shenzhen Best Electronics Co., Ltd. |
02/13/2026 | DXQ |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) |
Shenzhen Hingmed Medical Instrument Co., Ltd. |
02/13/2026 | DXN |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) |
Shenzhen Imdk Medical Technology Co., Ltd. |
02/13/2026 | DXN |
| K252420 | Wearable Breast Pump (Model W12) |
Shenzhen TPH Technology Co., Ltd. |
02/13/2026 | HGX |
| K252422 | Wearable Breast Pump (Model W2) |
Shenzhen TPH Technology Co., Ltd. |
02/13/2026 | HGX |
| K251852 | Ccell - In Vivo With Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) |
VPIX Medical, Inc. | 02/13/2026 | OWN |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) |
4Web, Inc. | 02/12/2026 | KWQ |
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) |
Guangzhou Hehong Biotech Co., Ltd. |
02/12/2026 | MQF |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test |
Healgen Scientific, LLC | 02/12/2026 | NFW |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) |
Karl Storz SE & CO. KG | 02/12/2026 | OWN |
| K253381 | Stealth AXiS™ Surgical System With Stealth AXiS™ Spine Clinical Application |
Medtronic Navigation, Inc. |
02/12/2026 | OLO |
| K251732 | Wrist Fracture System | Met One Technologies, LLC |
02/12/2026 | HRS |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) |
Puracath Medical, Inc. | 02/12/2026 | FPA |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; Cobas Pro Integrated Solutions |
Roche Diagnostics | 02/12/2026 | CFR |
| K253491 | ISE Indirect K For Gen.2; ISE Indirect Na For Gen.2; ISE Indirect Cl For Gen.2; Cobas Pro Integrated Solutions |
Roche Diagnostics | 02/12/2026 | CEM |
| K260108 | L12 LED Light Source With AIM | Stryker Endoscopy | 02/12/2026 | OWN |
| K254007 | LED Light Therapy Silicone Face Mask (kks-225, Kks-280, Kks-281) |
SZ KKS Silicone&Electronic Co., Ltd. |
02/12/2026 | OHS |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) |
Tianjin Huahong Technology Co., Ltd. |
02/12/2026 | FMK |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) |
Well-Life Healthcare , Ltd. |
02/12/2026 | KPI |
| K260177 | Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) |
Xenocor, Inc. | 02/12/2026 | GCJ |
| K251592 | SteriHub™ Disinfecting Device And Protective Cover |
1World Vista Medical | 02/11/2026 | QBP |
| K252084 | AI4CMR V2.0 | Ai4medimaging Medical Solutions S.A. |
02/11/2026 | QIH |
| K251992 | ArmSure Fluoroscopic Positioning System |
Savfe Co. , Ltd. | 02/11/2026 | OWB |
| K253049 | 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. |
02/11/2026 | IYN |
| K253488 | Ifuse INTRA Ti™ Implant System |
SI-BONE, Inc. | 02/11/2026 | OUR |
| K253032 | AXS Lift Intracranial Base Catheter |
Stryker Neurovascular | 02/11/2026 | QJP |
| K251813 | CURIS II RF Generator (REF 360100-05) |
Sutter Medizintechnik GmbH |
02/11/2026 | GEI |
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm |
Biodynamik, Inc. | 02/10/2026 | JDW |
| K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation |
02/10/2026 | OVB |
| K251515 | Solidex® Ti-Links And Screws | CreoDent Hudson Valley | 02/10/2026 | NHA |
| K252751 | Earflo (EF001) | Earflo, Inc. | 02/10/2026 | MJV |
| K252175 | LANDR Contact LENS Case | Fourth Axis, LLC | 02/10/2026 | LRX |
| K252459 | Multiflux 130 (F00013123); Multiflux 160 (F00013124) |
Fresenius Medical Care Renal Therapies Group, LLC |
02/10/2026 | KDI |
| K253545 | Vulcan Spinal System | K2m, Inc. | 02/10/2026 | NKB |
| K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) |
Medtronic Xomed, Inc. | 02/10/2026 | ETN |
| K253140 | CollOvine™ Wound Powder | Ovigenex, LLC | 02/10/2026 | KGN |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only |
Shenzhen RF Tech Co., Ltd. |
02/10/2026 | MOS |
| K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. |
02/10/2026 | QIH |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | 02/09/2026 | GXY |
| K251591 | Holter ECG And ABP System (HolterABP) |
Edan Instruments, Inc. | 02/09/2026 | DQK |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 02/09/2026 | DYB |
| K252873 | Q Interbody Instruments | K2m, Inc. | 02/06/2026 | OLO |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) |
Siemens Healthcare Diagnostics, Inc. |
02/06/2026 | JLW |
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | 02/06/2026 | MSV |
| K243348 | Athelas Home | Athelas, Inc. | 02/06/2026 | GKZ |
| K251577 | LAIA XR | Augmented Reality Software S.L. |
02/06/2026 | LLZ |
| K252058 | ROSA Knee System With UltraSound Imaging Platform (USIP) |
Balmoral Medical, LLC | 02/06/2026 | OLO |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 02/06/2026 | KCT |
| K253221 | Liver Fat Ultrasound Quantitative System, The FattaLab (FL-CC M1, FL-CC M1_Pro) |
Eieling Technology (Shenzhen) Limited |
02/06/2026 | IYO |
| K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture |
Ethicon, Inc. | 02/06/2026 | GAM |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR |
Fujifilm Corporation | 02/06/2026 | FDS |
| K253780 | SIGNA™ Bolt | Ge Medical Systems, LLC | 02/06/2026 | LNH |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) |
Kneevoice, Inc. | 02/06/2026 | DQD |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 02/06/2026 | LLZ |
| K251474 | Median LCS (internal Name) / Eyonis LCS (trade Name) (1.0) |
Median Technologies | 02/06/2026 | QDQ |
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) |
Philips Medizin Systeme Boeblingen GmbH |
02/06/2026 | MHX |
| K251507 | INTEGRE LIO | Quantel Medical | 02/06/2026 | HQF |
| K251218 | SafeBeat Rx App | Safebeat Rx, Inc. | 02/06/2026 | DQK |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. |
02/06/2026 | GEI |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories |
Stryker Leibinger GmbH & Co KG |
02/06/2026 | OLO |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | 02/06/2026 | HGX |
| K251517 | Encora X1 | Encora, Inc. | 02/05/2026 | QBC |
| K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter With Handpiece, CLEANER™ Vac Aspiration Canister |
Argon Medical Devices, Inc. |
02/05/2026 | QEW |
| K253959 | Primevision 3D | Dentsply Sirona | 02/05/2026 | OAS |
| K253779 | SIGNA™ Sprint Select | Ge Medical Systems, LLC | 02/05/2026 | LNH |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing With LINK |
Penumbra, Inc. | 02/05/2026 | QEW |
| K260012 | UltraScore™ Focused Force PTA Balloon |
Bard Peripheral Vascular, Inc. |
02/04/2026 | PNO |
| K260038 | E3D™-C Interbody System | Evolution Spine | 02/04/2026 | OVE |
| K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS |
02/04/2026 | QHE |
| K250773 | Luna® Ti Interbody Fusion System |
Spinal Elements, Inc. | 02/04/2026 | MAX |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) |
Yadu Medical (Henan) Co., Ltd. |
02/04/2026 | FYA |
| K252623 | G7® Revision Acetabular System |
Zimmer, Inc. | 02/04/2026 | LPH |
| K252438 | Explant Express | Applied Medical Technology, Inc. |
02/03/2026 | QVS |
| K252676 | The Circadia C300 System (C300) |
Circadia Health, Inc. | 02/03/2026 | DRT |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. | 02/03/2026 | QBJ |
| K253282 | ZSmile System | Dror Orthodesign , Ltd. | 02/03/2026 | NXC |
| K250644 | MSS - Monobloc Stem | Medacta International S.A. |
02/03/2026 | PHX |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology |
Medtronic Minimed | 02/03/2026 | QJI |
| K252909 | Diagnostic X-Ray Equipment Model POCT22 |
Ningbo Runyes Medical Instrument Co., Ltd. |
02/03/2026 | EHD |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System |
Stryker GmbH | 02/03/2026 | HSB |
| K252087 | Navigation Module Of The Cortium® System |
Ulrich Medical USA, Inc. | 02/03/2026 | OLO |
| K252048 | 808nm Semiconductor Laser Hair Removal Machine |
Xi'An Taibo Electronic Technology Co., Ltd. |
02/03/2026 | GEX |
| K252011 | CHIKAI Nexus Petit | Asahi Intecc Co., Ltd. | 02/02/2026 | MOF |
| K251582 | Redermax Antibacterial Wound Matrix |
Beijing Kreate Medical Co., Ltd. |
02/02/2026 | FRO |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. |
02/02/2026 | DZE |
| K252649 | TAP2D | Nano-X Imaging , Ltd. | 02/02/2026 | IZF |
| K251200 | Vital Signs | Oxehealth Limited | 02/02/2026 | QME |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) |
Merit Medical Ireland, Ltd. |
01/31/2026 | DQX |
| K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx |
01/30/2026 | POK |
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) |
Asistan Medikal | 01/30/2026 | SCL |
| K251981 | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | 01/30/2026 | GEX |
| K253318 | Clungene RSV Antigen Rapid Test |
Hangzhou Clongene Biotech Co., Ltd. |
01/30/2026 | GQG |
| K254305 | BAROguard Donor Lung Preservation System |
Paragonix Technologies, Inc. |
01/30/2026 | KDN |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. |
01/30/2026 | EIH |
| K251407 | Motor Handpiece And Control Unit (SDI10) |
Saeshin Precision Co., Ltd. |
01/30/2026 | EBW |
| K252457 | Disposable Distal End Tape Hood |
Shanghai SeeGen Photoelectric Technology Co., Ltd. |
01/30/2026 | FDF |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) |
Shenzhen Jianchao Intelligent Technology Co., Ltd. |
01/30/2026 | OHS |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) |
Shenzhen Peninsula Medical Group |
01/30/2026 | GEI |
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. |
01/30/2026 | DWF |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits |
HR Healthcare | 01/29/2026 | EZD |
| K253763 | Y-Knotless™ Flex Anchors | Conmed Corporation | 01/29/2026 | MBI |
| K252347 | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. |
01/29/2026 | INI |
| K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. |
01/29/2026 | INI |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) |
Fresenius Medical Care Renal Therapies Group, LLC |
01/29/2026 | KPO |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) |
Hangzhou Hawk Optical Electronic Instruments Co., Ltd. |
01/29/2026 | GCJ |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 01/29/2026 | NHA |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. |
01/29/2026 | IOR |
| K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 01/29/2026 | OUR |
| K252091 | Surgical Reality Viewer | Medicalvr B.V. | 01/29/2026 | QIH |
| K252684 | Labcorp Fentanyl Urine Visual Test |
Medtox Diagnostics, Inc. | 01/29/2026 | DJG |
| K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | 01/29/2026 | QIH |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 01/29/2026 | NHA |
| K251354 | UV Smart D60 | UV Smart Technologies B.V. |
01/29/2026 | SCS |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. |
01/29/2026 | INI |
| K253842 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp |
01/28/2026 | LYK |
| K252834 | Sacroiliac Joint Truss System (SJTS) |
4Web Medical | 01/28/2026 | OUR |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 01/28/2026 | MBI |
| K253254 | GBT Machine Airflow Prophylaxis Master |
E.M.S Electro Medical Systems S.A |
01/28/2026 | ELC |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. |
01/28/2026 | QKB |
| K253224 | MySOZO Software Version 6.0.1.2 (SW Version 6.0.1.2) |
ImpediMed Limited | 01/28/2026 | OBH |
| K252164 | NorthStar™ Mapping System | Imricor Medical Systems | 01/28/2026 | DQK |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing |
Koru Medical Systems, Inc. |
01/28/2026 | FRN |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology |
Medacta International S.A. |
01/28/2026 | LPH |
| K251622 | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. |
01/28/2026 | IRP |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) |
Shenzhen Kaiyan Medical Equipment Co., Ltd. |
01/28/2026 | OHS |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 01/28/2026 | DRT |
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. |
01/28/2026 | FRG |
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement |
Xelite Biomed , Ltd. | 01/28/2026 | NDN |
| K251195 | BriefCase-Triage | Aidoc Medical , Ltd. | 01/27/2026 | QAS |
| K254221 | Optima Coil System (OptiOne Coil System) |
Balt USA, LLC | 01/27/2026 | HCG |
| K251995 | Access Anti-hav IgM | Beckman Coulter, Inc. | 01/27/2026 | LOL |
| K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | 01/27/2026 | GEI |
| K254220 | Reusable 3 Button Fingerswitch Wand |
Soniquence, LLC | 01/27/2026 | GEI |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System |
Eyas Medical Imaging, Inc. |
01/26/2026 | LNH |
| K251670 | MAC 7 Resting ECG Analysis System |
Ge Medical Systems Information Technologies, Inc. |
01/26/2026 | DPS |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) |
Outset Medical, Inc. | 01/26/2026 | KDI |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
01/24/2026 | GEX |
| K252753 | Vydence Family Of Lasers | Vydence Medical Industria E Commercio Ltda |
01/24/2026 | GEX |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | 01/23/2026 | GCJ |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. |
01/23/2026 | LZA |
| K243349 | BodyGuardian Remote Monitoring System (BGRMS V3.0) |
Boston Scientific Cardiac Diagnostic Technologies, Inc. |
01/23/2026 | DSI |
| K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) |
Devicor Medical Products, Inc. |
01/23/2026 | NEU |
| K253285 | Elitone For Men | Elidah, Inc. | 01/23/2026 | QAJ |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) |
01/23/2026 | MOS |
| K253748 | Life Spine ProLift & ProLift Lateral And ProLift Lateral Fixated Expandable Spacer System |
Life Spine, Inc. | 01/23/2026 | MAX |
| K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. |
01/23/2026 | QKB |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System |
Point Robotics MedTech, Inc. |
01/23/2026 | OLO |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex |
Randox Laboratories Limited |
01/23/2026 | DJG |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) |
Shenzhen Kaiyan Medical Equipment Co., Ltd. |
01/23/2026 | OAP |
| K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) |
Shenzhen Rainbow Technology Co., Ltd. |
01/23/2026 | OHS |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 01/23/2026 | FRO |
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System |
Astura Medical | 01/22/2026 | PML |
| K251511 | PhenoMATRIX | Copan Wasp Srl | 01/22/2026 | PPU |
| K253652 | Genie MAX Large Bore Introducer Sheath |
Cultiv8 1, LLC | 01/22/2026 | DYB |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 01/22/2026 | KGN |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. |
01/22/2026 | NHA |
| K253315 | Straumann Variobase Abutments XC For Bridge/Bar |
Institut Straumann AG | 01/22/2026 | NHA |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System |
Lima Corporate S.P.A. | 01/22/2026 | PHX |
| K252307 | Getinge GSS67N Series Steam Sterilizer |
Maquet GmbH (A Getinge Group Company) |
01/22/2026 | FLE |
| K253498 | Pump In Style® Pro+ | Medela, LLC | 01/22/2026 | HGX |
| K252984 | Perin Health System (PHD80060-2) |
Perin Health Devices, LLC |
01/22/2026 | DRG |
| K253735 | AV Vascular | Philips Medical Systems Nederland B.V. |
01/22/2026 | QIH |
| K253057 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | 01/22/2026 | QIH |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System |
Arthrex, Inc. | 01/21/2026 | HRS |
| K252369 | Boston Pico755 | Boston Aesthetics, Inc. | 01/21/2026 | GEX |
| K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) |
01/21/2026 | QFX |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. |
01/21/2026 | EBF |
| K254165 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. |
01/21/2026 | NKG |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) |
Merit Medical Ireland, Ltd. |
01/21/2026 | DQX |
| K251281 | Nova Max Creat Egfr Monitoring System |
Nova Biomedical Corporation |
01/21/2026 | SHB |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) |
Varian Medical Systems, Inc. |
01/21/2026 | IYE |
| K253730 | RoVo Mechanical Thrombectomy System |
Verge Medical, Inc. | 01/21/2026 | QEW |
| K251318 | VariFuse Adjustable Infusion Catheter |
Argon Medical Devices, Inc. |
01/20/2026 | QEY |
| K253291 | Excelsior System | Blue Ocean Global | 01/20/2026 | KTT |
| K253597 | Aplio Beyond And Aplio Me Software V2.0 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
01/20/2026 | IYN |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 Detector, Lux HD 43 Detector |
Carestream Health | 01/20/2026 | KPR |
| K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries With Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries With Drainage Holes |
Cooper Surgical | 01/20/2026 | HHW |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | 01/20/2026 | DWF |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) |
Scivita Medical Technology Co., Ltd. |
01/20/2026 | FBN |
| K253173 | Uct 780 With Uws-ct-dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
01/20/2026 | JAK |
| K252537 | Rusch SoftSimplastic Foley Catheters |
Teleflex Medical Sdn. Bhd. |
01/20/2026 | EZL |
| K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. |
01/18/2026 | DSA |
| K254085 | CARTO™ 3 EP Navigation System V9.0 With PIU Plus |
Biosense Webster, Inc. | 01/18/2026 | DQK |
| K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. |
01/17/2026 | JXI |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter |
Medtronic, Ireland | 01/17/2026 | LOX |
| K252960 | SOLIUS PRO UVB Light Panel | Solius Labs, Inc. | 01/16/2026 | SGZ |
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | 01/16/2026 | LCJ |
| K250135 | WAVE Clinical Platform (2.0.000) |
Baxter Healthcare Corp/ Excel Medical |
01/16/2026 | MWI |
| K251721 | Xpert GI Panel | Cepheid | 01/16/2026 | PCH |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System |
Curiteva, Inc. | 01/16/2026 | ODP |
| K251448 | FL-10000U Respiratory Humidifier |
Flexicare Medical Limited. |
01/16/2026 | BTT |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis Hypogaea); Capture Reagent F076, Bos D 4 A-lactalbumin, Milk; Capture Reagent F077, Bos D 5 Ss-lactoglobulin, Milk; Capture Reagent F232, Gal D 2 Ovalbumin, Egg |
Hycor Biomedical | 01/16/2026 | DHB |
| K251739 | Da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. | 01/16/2026 | NAY |
| K253556 | Da Vinci SP Surgical System (SP1098); Da Vinci E-200 Generator |
Intuitive Surgical, Inc. | 01/16/2026 | NAY |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
01/16/2026 | DJG |
| K251744 | Affinity Pixie™ Arterial Filter With Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter |
Medtronic | 01/16/2026 | DTM |
| K251900 | MY01 Continuous Compartmental Pressure Monitor |
MY01, Inc. | 01/16/2026 | LXC |
| K251367 | OptoMonitor 3 | Opsens, Inc. | 01/16/2026 | DXO |
| K251353 | Eyer 2 | Phelcom Technologies | 01/16/2026 | HKI |
| K254186 | Azurion R3.1 | Philips Medical Systems B.V. |
01/16/2026 | OWB |
| K251934 | Qxr-detect | Qure.Ai Technologies | 01/16/2026 | MYN |
| K252634 | Imagine® Enterprise Suite | Softlink International Private Limited |
01/16/2026 | QIH |
| K251790 | SeptAlign | Spirair, Inc. | 01/16/2026 | NHB |
| K252767 | Actitens Mini | Sublimed | 01/16/2026 | GZJ |
| K251714 | Ion-C | SurGenTec, LLC | 01/16/2026 | MRW |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | 01/16/2026 | QJP |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | 01/16/2026 | GKZ |
| K251341 | VITAL Tubing Sets For Hemodialysis |
Vital Healthcare Sdn. Bhd. |
01/16/2026 | FJK |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH |
01/16/2026 | NGX |
| K251961 | SDS Growing Rod | BAAT Medical Products B.V. |
01/15/2026 | PGM |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System |
Curiteva, Inc. | 01/15/2026 | ODP |
| K252934 | Diagnocat | DGNCT, LLC | 01/15/2026 | MYN |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) |
Elekta Solutions AB | 01/15/2026 | IYE |
| K252567 | AltiVate Reverse® ADLC Glenosphere |
Encore Medical, L.P. | 01/15/2026 | PHX |
| K251458 | Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. |
01/15/2026 | ITI |
| K251254 | Ignite RF System | Inmode , Ltd. | 01/15/2026 | GEI |
| K253925 | Aventus Thrombectomy System | Inquis Medical | 01/15/2026 | QEZ |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) |
Maxx Orthopedics, Inc. | 01/15/2026 | LZO |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) |
Medtronic Minimed, Inc. | 01/15/2026 | QFG |
| K251831 | Bio-Medicus Life Support Catheter And Introducer |
Medtronic, Inc. | 01/15/2026 | QHW |
| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | 01/15/2026 | PSZ |
| K251357 | Esperance Phlo Aspiration System |
Phenox, Ltd. | 01/15/2026 | NRY |
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) |
Shanghai Bangbang Robotics Co., Ltd. |
01/15/2026 | ITI |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. |
01/15/2026 | PHX |
| K253023 | BIOGRAPH One | Siemens Healthineers AG | 01/15/2026 | OUO |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask |
Sleepnet Corporation | 01/15/2026 | BZD |
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) |
Thera B Medical Products | 01/15/2026 | LBI |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) |
TriMed, Inc. | 01/15/2026 | HRS |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface |
Brainlab SE | 01/14/2026 | IYE |
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff |
Cardinalhealth | 01/14/2026 | LZC |
| K251996 | ENTire IRE System | Entire Medical , Ltd. | 01/14/2026 | GEI |
| K251419 | Laboratorios Biogalenic Sterile Water For Inhalation, USP |
Laboratorios Biogalenic S.A. DE C.V. |
01/14/2026 | BTT |
| K253585 | SmartGuard Technology; Predictive Low Glucose Technology |
Medtronic Minimed, Inc. | 01/14/2026 | QJI |
| K253511 | Concerto Versa™ Detachable Coil |
Medtronic, Inc. | 01/14/2026 | KRD |
| K252958 | METICULY Patient-specific Titanium Mesh Implant |
Meticuly Co., Ltd. | 01/14/2026 | GXN |
| K254190 | Ds Base 1.5T; Ds Base 3.0T; Ds Head 1.5T; Ds Head 3.0T; Ds HeadNeck 1.5T; Ds HeadNeck 3.0T |
Philips Medical Systems Nederland B.V. |
01/14/2026 | MOS |
| K252219 | Cervical Interbody And VBR Fusion System |
Sync Surgical | 01/14/2026 | ODP |
| K252579 | Orthoscan TAU MVP Mini C-Arm System |
Ziehm-Orthoscan, Inc. | 01/14/2026 | OXO |
| K253248 | Bright Cavity Liner | Dmp Dental Industry S.A. | 01/13/2026 | EJK |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, And Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, And Simulated Gastric Acid |
Kossan International Sdn Bhd |
01/13/2026 | LZA |
| K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant |
Miach Orthopaedics, Inc. | 01/13/2026 | QNI |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) |
Spectrum Dynamics Medical, Ltd. |
01/13/2026 | KPS |
| K252461 | Swedge™ Pedicle Screw Fixation System Bezier Rod |
Spinal Resources, Inc. | 01/13/2026 | NKB |
| K254014 | Connected OR Hub With Device And Voice Control; SDC4K Information Management System With Device And Voice Control |
Stryker Endoscopy | 01/13/2026 | GCJ |
| K252807 | Arthrex Anatomic Lapidus Plates And I-Beam Lapidus Plates |
Arthrex, Inc. | 01/12/2026 | HRS |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) |
Beatles Medical Supplies (Xiantao) Co., Ltd. |
01/12/2026 | FXX |
| K251988 | Boston Iface (Boston Iface) | Boston Aesthetics, Inc. | 01/12/2026 | GEI |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division |
01/12/2026 | EBW |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | 01/12/2026 | IOR |
| K251388 | Dental Air-motor Handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) |
Foshan Topmed Dental Co., Ltd. |
01/12/2026 | EFB |
| K251389 | High Speed Air Turbine Handpiece |
Foshan Topmed Dental Co., Ltd. |
01/12/2026 | EFB |
| K253167 | Any-Paste | Mediclus Co., Ltd. | 01/12/2026 | KIF |
| K251558 | Precision AI Surgical Planning System (PAI-SPS) |
Precision AI Pty, Ltd. | 01/12/2026 | QHE |
| K252962 | DYNAMIS™ Navigation System | Promethean Restorative, LLC |
01/12/2026 | OLO |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) |
Shenzhen Hingmed Medical Instrument Co., Ltd. |
01/12/2026 | DXN |
| K250890 | SBC1 Cream | Sioxmed, LLC | 01/12/2026 | FRO |
| K252913 | Break Wave | Sonomotion, Inc. | 01/12/2026 | LNS |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. |
01/12/2026 | GEH |
| K252842 | SafeOp 3: Neural Informatix System |
Alphatec Spine, Inc. | 01/11/2026 | GWF |
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) |
GI Windows, Inc. | 01/09/2026 | SAH |
| K252589 | Corvair Monza | AliveCor, Inc. | 01/09/2026 | MHX |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) |
Ethicon Endo-Surgery, LLC |
01/09/2026 | OXC |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 01/09/2026 | PHX |
| K251139 | KabiHelp® Uno; KabiHelp® Advance Plus |
Fresenius Kabi AG | 01/09/2026 | KPE |
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. |
01/09/2026 | GFO |
| K252339 | Iotasoft® Insertion System | Iotamotion, Inc. | 01/09/2026 | QQH |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, And SP Series |
Liaoning Upcera Co., Ltd. |
01/09/2026 | EIH |
| K252847 | NextAR Hip Platform | Medacta International S.A. |
01/09/2026 | SBF |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8 D,RN3D,MJ4D,RN1D,RN2D) |
Ningbo Ranor Medical Technology Co., Ltd. |
01/09/2026 | DXN |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer |
Nova Biomedical Corporation |
01/09/2026 | CGX |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) |
Solo Pace, Inc. | 01/09/2026 | DQX |
| K253075 | Mobility Scooter (Air Classic); Mobility Scooter (Air Traveller); Mobility Scooter (Air Traveller2.0) |
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. |
01/09/2026 | INI |
| K251157 | Core Metabolic | Truvian Health | 01/09/2026 | CIX |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) |
Unimed Medical Supplies, Inc. |
01/09/2026 | DXQ |
| K253639 | View | Ge Healthcare | 01/08/2026 | LLZ |
| K253370 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics |
01/08/2026 | IYN |
| K252794 | Vision-MR™ Diagnostic Catheter |
Imricor Medical Systems, Inc. |
01/08/2026 | DRF |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device |
Intelivation Technologies |
01/08/2026 | ODP |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 01/08/2026 | DZE |
| K252759 | Revyve® Antimicrobial Skin And Wound Cleanser |
Kane Biotech, Inc. | 01/08/2026 | FRO |
| K253512 | MiniMed Go App | Medtronic Minimed | 01/08/2026 | NDC |
| K251160 | Sterile Temperature Probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) |
Shenzhen Med-Link Electronics Tech Co., Ltd. |
01/08/2026 | FLL |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. |
01/08/2026 | LLZ |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 01/08/2026 | MAX |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) |
Tornier, Inc. | 01/08/2026 | PHX |
| K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory |
01/08/2026 | KNG |
| K253308 | Materialise Personalized Guides And Models For Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models |
Materialise NV | 01/07/2026 | PPT |
| K253923 | PuraStat | 3-D Matrix Europe SAS | 01/07/2026 | PHN |
| K253924 | PuraStat | 3-D Matrix Europe SAS | 01/07/2026 | QAU |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body |
Aidoc Medical , Ltd. | 01/07/2026 | QAS |
| K252507 | SmileInspector | Amv Consulting, LLC | 01/07/2026 | PNN |
| K251207 | Sangria™ Thrombectomy System | Avantec Vascular Corporation |
01/07/2026 | QEW |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited |
01/07/2026 | NXC |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | 01/07/2026 | MYN |
| K253366 | LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics |
01/07/2026 | IYN |
| K250305 | Reprocessed Agilis NxT Steerable Introducer |
Innovative Health | 01/07/2026 | PNE |
| K252727 | Neodent InLab Validated Workflow |
JJGC Indústria e Comércio de Materiais Dentários S.A. |
01/07/2026 | NHA |
| K252890 | ZenSeal Pro | Kerr Corporation | 01/07/2026 | KIF |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) |
Medtronic Sofamor Danek USA, Inc. |
01/07/2026 | NKB |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 01/07/2026 | BZD |
| K253990 | KHEIRON® Spinal Fixation System, Including Patient Specific K-ROD |
S.M.A.I.O | 01/07/2026 | NKB |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) |
Shenzhen Best Electronics Co., Ltd. |
01/07/2026 | DQA |
| K253158 | VyBrate™ VBR System | Vy Spine, LLC | 01/07/2026 | MQP |
| K253793 | Materialise TKA Guide System | Materialise NV | 01/06/2026 | JWH |
| K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 01/06/2026 | MBI |
| K252894 | Aprevo® Cervical Interbody System |
Carlsmed, Inc. | 01/06/2026 | ODP |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems |
01/06/2026 | HRS |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 01/06/2026 | PAY |
| K252886 | Pen Needle | Hh Global Technology, Inc. |
01/06/2026 | FMI |
| K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited |
01/06/2026 | SGR |
| K252749 | Medconn 8K Glycated Hemoglobin Test System |
Shanghai Medconn Medical Technology Co., Ltd. |
01/06/2026 | PDJ |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 01/06/2026 | QJP |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution |
Innovacyn, Inc. | 01/05/2026 | FRO |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. |
01/05/2026 | QJP |
| K253008 | Mailink | Maihub Corp. | 01/05/2026 | LLZ |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | 01/05/2026 | FXX |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | 01/05/2026 | IYE |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
01/05/2026 | IYN |
| K251630 | Atellica IM Total PSA II (tPSAII) |
Siemens Healthcare Diagnostics, Inc. |
01/05/2026 | LTJ |
| K251178 | Ready To Use Nelaton Catheter | Jamjoom Fullcare Corporation |
01/02/2026 | EZD |
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. |
01/02/2026 | INI |
| K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | 01/02/2026 | GXP |
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit |
ZuriMED Technologies AG | 01/02/2026 | OWX |
| K252951 | Genesis Sleep | Neurofield, Inc. | 12/31/2025 | QJQ |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 12/31/2025 | HWC |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) |
Arc Trauma, LLC | 12/31/2025 | DXC |
| K253305 | TENS AND EMS (TENS And Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) |
Shenzhen Jiantuo Electronics Co., Ltd. |
12/31/2025 | NUH |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 12/31/2025 | NEU |
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) |
Techno-Path Manufacturing , Ltd. |
12/30/2025 | QCH |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 X 10 Mm |
Arthrex, Inc. | 12/30/2025 | MBI |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer |
Lucas Lifecare | 12/30/2025 | FLE |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. |
12/30/2025 | KPS |
| K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. |
12/30/2025 | QIH |
| K251091 | Lipids | Truvian Health | 12/30/2025 | CHH |
| K253343 | Celebrace Software | Celebrace | 12/29/2025 | PNN |
| K251025 | Mon-a-Therm™ Esophageal Stethoscope With Temperature Sensor 400TM (90041, 90042, 90043, 90049) |
Covidien, LLC | 12/29/2025 | BZT |
| K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT With TaperGuard™ Cuff, Distal With Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT With TaperGuard™ Cuff, Proximal With Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal With Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal With Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT |
Covidien, LLC | 12/29/2025 | JOH |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. |
12/29/2025 | CAW |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) |
Shenzhen Fansizhe Science And Technology Co., Ltd. |
12/29/2025 | OHT |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent |
Taewoong Medical Co., Ltd. |
12/29/2025 | FGE |
| K253325 | ZipToe™ Hammertoe Fusion System |
Toetal Solutions | 12/29/2025 | HTY |
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 12/24/2025 | OHS |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) |
Light Tree Ventures Europe B.V. |
12/24/2025 | OAP |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) |
Shenzhen Saidi Light Therapy Technology Co., Ltd. |
12/24/2025 | OHS |
| K253342 | PICO-K | Speclipse, Inc. | 12/24/2025 | GEX |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, And Nano L12 EXP) |
Edan Instruments, Inc. | 12/23/2025 | IYN |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | 12/23/2025 | NFO |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens With UV Blocking For Presbyopia (EDOF) |
Bruno Vision Care, LLC | 12/23/2025 | LPL |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 12/23/2025 | OBO |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 |
Diasorin Molecular, LLC | 12/23/2025 | QOF |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,H LG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) |
Dongguan Yijiaming Technology Co., Ltd. |
12/23/2025 | OHS |
| K251958 | VEINOPLUS Back | Dynapulse Medical | 12/23/2025 | |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 12/23/2025 | LNH |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) |
Guangdong Prestige Technology Co., Ltd. |
12/23/2025 | INI |
| K251800 | Healgen® URS Test Strips | Healgen Scientific, LLC | 12/23/2025 | JMT |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
Healgen Scientific, LLC | 12/23/2025 | NGL |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) |
Hong Qiangxing (Shenzhen) Electronics Limited |
12/23/2025 | NUH |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp Spp.); Capture Reagent F207, Clam (Mercenaria Mercenaria); Capture Reagent F256, Walnut (Juglans Spp.) ; Capture Reagent I006, German Cockroach (Blatella Germanica) |
Hycor Biomedical | 12/23/2025 | DHB |
| K253072 | Paruu Wearable Breast Pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) |
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. |
12/23/2025 | HGX |
| K253341 | Custom Abutments AS | Medentika GmbH | 12/23/2025 | NHA |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) |
Medimaging Integrated Solution, Inc (Miis) |
12/23/2025 | HRX |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | 12/23/2025 | DZI |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 12/23/2025 | NHA |
| K253675 | OsteoRemedies Hip Spacer System |
Osteoremedies, LLC | 12/23/2025 | KWL |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC |
12/23/2025 | DZE |
| K252145 | GEN5™ And GEN5+™ 3.3mmD Dental Implants |
Paragon Implant Mfg., LLC |
12/23/2025 | DZE |
| K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. |
12/23/2025 | OHT |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) |
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. |
12/23/2025 | JOJ |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) |
Shenzhen Siken 3D Technology Development Co., Ltd. |
12/23/2025 | NFO |
| K253239 | Active-V Total Knee System; World Total Knee System |
Signature Orthopaedics Pty, Ltd. |
12/23/2025 | MBH |
| K253122 | Sim&Size | Sim&Cure | 12/23/2025 | PZO |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 12/23/2025 | MUJ |
| K253281 | UpDoc | Updoc, Inc. | 12/23/2025 | NDC |
| K252361 | AccurECG Analysis System (v2.0) |
Accurkardia, Inc. | 12/22/2025 | DPS |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | 12/22/2025 | HTN |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G And BT-PDS-SERIES-G |
Bioteque Corporation | 12/22/2025 | FGE |
| K250959 | BioticsAI | Bioticsai, Inc. | 12/22/2025 | IYN |
| K252611 | Aprevo® Cervical Plating System |
Carlsmed, Inc. | 12/22/2025 | KWQ |
| K251605 | DIMPLO Implant System | Dimplo , Ltd. | 12/22/2025 | DZE |
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation |
12/22/2025 | PKP |
| K252981 | EmbraceMini | Empatica S.R.L. | 12/22/2025 | LEL |
| K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device |
Ethicon, Inc. | 12/22/2025 | GAM |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) |
Globus Medical, Inc. | 12/22/2025 | OVE |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 12/22/2025 | FMF |
| K253664 | SKOUT System | Iterative Health | 12/22/2025 | QNP |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | 12/22/2025 | FXX |
| K252673 | LacertaMatrix | Lacerta Life Science | 12/22/2025 | KGN |
| K252068 | MC2 Portable X-ray System | Oxos Medical | 12/22/2025 | OWB |
| K252856 | PeekMed Web | Peek Health, S.A. | 12/22/2025 | QIH |
| K252557 | Lumify Diagnostic Ultrasound System |
Philips Ultrasound, LLC | 12/22/2025 | IYN |
| K250756 | Pression Wave PRO External Counter-Pulsation System |
Pression, Inc. | 12/22/2025 | DRN |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. |
12/22/2025 | CAW |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) |
12/22/2025 | MUJ |
| K252616 | Portable Oxygen Concentrator (JLO-190P) |
Shenzhen Homed Medical Device Co., Ltd. |
12/22/2025 | CAW |
| K251783 | Inspire HCR And HCR DUAL Cardiotomy Reservoirs |
Sorin Group Italia S.R.L. |
12/22/2025 | DTN |
| K253339 | Theracor | Stimlabs, LLC | 12/22/2025 | KGN |
| K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation |
12/22/2025 | FZP |
| K253903 | InnoClip Disposable Clip Applier |
Taiwan Surgical Corporation |
12/22/2025 | FZP |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 12/22/2025 | OLO |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) |
Zhejiang Gongdong Medical Technology Co., Ltd. |
12/22/2025 | MMK |
| K251159 | Power Wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. |
12/22/2025 | ITI |
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | 12/19/2025 | NEZ |
| K251469 | Endura™ Ureteral Stent And Stent Set |
Cathegenix (Xiamen) Co., Ltd. |
12/19/2025 | FAD |
| K252284 | Emurmur Heart AI | Csd Labs | 12/19/2025 | DQD |
| K251152 | DBLG2 | Diabeloop | 12/19/2025 | QJI |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay |
Diazyme Laboratories, Inc. |
12/19/2025 | DFH |
| K252974 | EMPOWR Knee | Encore Medical, L.P. | 12/19/2025 | JWH |
| K253479 | Optiflow Switch+ Filtered Nasal Interface With CO2 Sampling (AA042J) |
Fisher &Paykel Healthcare , Ltd. |
12/19/2025 | BTT |
| K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio |
12/19/2025 | HRS |
| K252342 | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) |
Guangdong Youmeng Electrical Technology Co., Ltd. |
12/19/2025 | HGX |
| K252754 | Wearable Electric Breast Pump (YM-8803) |
Guangdong Youmeng Electrical Technology Co., Ltd. |
12/19/2025 | HGX |
| K252029 | AI-CVD | HeartLung Corporation | 12/19/2025 | QIH |
| K254063 | Icem Universal Plus | Kulzer, LLC | 12/19/2025 | EMA |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | 12/19/2025 | KTI |
| K251730 | LIA Console (542-7) | Leadoptik, Inc. | 12/19/2025 | NQQ |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) |
Medicrea International S.A.S. (Medtronic) |
12/19/2025 | MAX |
| K250864 | MatriDerm Plus+ Bi-Layer | Medskin Solutions Dr. Suwelack AG |
12/19/2025 | KGN |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) |
Medtronic, Inc. | 12/19/2025 | DQY |
| K252892 | SCOUT MD Surgical Guidance System |
Merit Medical Systems, Inc. |
12/19/2025 | NEU |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. |
12/19/2025 | ODP |
| K251143 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) |
Ningbo Ranor Medical Science & Technology Co., Ltd. |
12/19/2025 | DXN |
| K251037 | Rectal Applicator | Nucletron B.V. | 12/19/2025 | JAQ |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. |
12/19/2025 | CBK |
| K253161 | Balanced Knee System TriMax Porous Femoral Components |
Ortho Development Corp. | 12/19/2025 | MBH |
| K253613 | Monkey Rings External Ring Fixation System |
Paragon 28, Inc. | 12/19/2025 | KTT |
| K251572 | Erapid With Etrack System | Pari Respiratory Equipment, Inc. |
12/19/2025 | CAF |
| K250976 | Airbile-100 | Poskom Co., Ltd. | 12/19/2025 | IZL |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
12/19/2025 | FRO |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 12/19/2025 | MUJ |
| K253733 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | 12/19/2025 | DQK |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U) |
Sanhe Lefis Electronics Co., Ltd. |
12/19/2025 | GEX |
| K251077 | JOULE 1064nm System And Accessories |
Sciton, Inc. | 12/19/2025 | GEX |
| K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. |
12/19/2025 | PGY |
| K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) |
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. |
12/19/2025 | OHS |
