| SPINEART Navigation Instrument System (K242890) | Spineart SA | 2025-03-07 |
| FRONT-LINE Field Sterilizer (FL135) (K243801) | Fort Defiance Industries, LLC | 2025-03-07 |
| CuffTrek (K242642) | Shanghai Longmann Tech Co., Ltd. | 2025-03-07 |
| Lelo Hex Lubricated Natural Rubber Latex Condom (K243421) | Lelo, Inc. | 2025-03-07 |
| Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) (K243535) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2025-03-07 |
| APTUS Hand System; APTUS Elbow Dorsal Olecranon (K243610) | Medartis AG | 2025-03-07 |
| Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (K243724) | Zimmer, Inc. | 2025-03-06 |
| Sterile Water USP and Sterile 0.9% Normal Saline USP (K243001) | Laboratorios Biogalenic S.A. DE C.V. | 2025-03-06 |
| XCELLARISPRO TWIST microneedling device (K241790) | Dermaroller GmbH | 2025-03-06 |
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K243578) | Miach Orthopaedics, Inc. | 2025-03-06 |
| Philips IntelliSite Pathology Solution 5.1 (K243871) | Philips Medical Systems Nederland B.V. | 2025-03-06 |
| LVivo Seamless (K243331) | Dia Imaging Analysis, Ltd. | 2025-03-06 |
| BD Phoenix™ Automated Microbiology System (K250344) | Becton, Dickinson and Company | 2025-03-06 |
| Versacem Acetabular Shell and Double Mobility HC Liners (K241767) | Medacta International S.A. | 2025-03-06 |
| PureLift GLOW (K243587) | Xtreem Pulse, LLC | 2025-03-06 |
| Intra-Operative Positioning System (IOPS®) (K243842) | Centerline Biomedical, Inc. | 2025-03-06 |
| Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (K241734) | Well Lead Medical Co., Ltd. | 2025-03-05 |
| Access Cortisol; DxC 500i Clinical Analyzer (K242190) | Beckman Coulter, Inc. | 2025-03-05 |
| Mako Total Hip Application 5.0 (K243751) | Mako Surgical Corp. | 2025-03-05 |
| NovoSorb® MTX (K242149) | Polynovo Biomaterials Pty, Ltd. | 2025-03-05 |
| Prostate MR AI (VA10A) (K241770) | Siemens Healthcare GmbH | 2025-03-05 |
| CROSSLEAD 0.018inch (K242597) | Asahi Intecc Co., Ltd. | 2025-03-05 |
| TITANEX Screw Systems (K250304) | Vilex, LLC | 2025-03-05 |
| Biolox® Delta Revision heads (K243809) | Limacorporate | 2025-03-04 |
| Ceevra Reveal 3+ (K243933) | Ceevra, Inc. | 2025-03-04 |
| Disposable Cytology Brush (AF series) (K241679) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-03-04 |
| Calibrate Interbody Systems (K243461) | Alphatec Spine, Inc. | 2025-03-04 |
| iPhysio® System (K232383) | Euroteknika | 2025-03-04 |
| EnergyLounger (TY-01) (K241947) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-03-03 |
| VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (K243380) | Olympus Medical Systems Corporation | 2025-03-03 |
| HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 (K243881) | Bracco Diagnostics, Inc. | 2025-03-03 |
| LVivo Software Application (K243235) | Dia Imaging Analysis, Ltd. | 2025-03-03 |
| JLK-SDH (K243611) | JLK, Inc. | 2025-03-03 |
| Titanium Flexible Geometry FSD Applicator Set (GM11013400) (K243939) | Varian Medical Systems, Inc. | 2025-03-03 |
| Q Switched Nd:YAG Laser machine (QNHF-01) (K242943) | Beijing Nubway S&T Co., Ltd. | 2025-03-03 |
| da Vinci SP Advanced Access Port Kit (432701) (K243582) | Intuitive Surgical, Inc. | 2025-02-28 |
| 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) (K244054) | Quality Electrodynamics | 2025-02-28 |
| Silver Fluoride Hypersensitivity Varnish (K241041) | Young Dental Manufacturing Co. 1, LLC | 2025-02-28 |
| E1000 Dx Digital Pathology Solution (K241717) | Shandon Diagnostics Limited | 2025-02-28 |
| pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (K242676) | Phenox Limited | 2025-02-28 |
| Portable Oxygen Concentrator (P2-TOC) (K242718) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-02-28 |
| Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) (K241374) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-02-28 |
| Airmod (K242798) | Heroic Faith International , Ltd. | 2025-02-28 |
| Xpert C. difficile/Epi (K243730) | Cepheid® | 2025-02-28 |
| Synea Fusion Handpieces (Intensiv & Profin) (K242179) | W&H Dentalwerk Bürmoos GmbH | 2025-02-28 |
| Pulse Oximeter ( PO2, PO2A, PO2B) (K242876) | Shenzhen Viatom Technology Co., Ltd. | 2025-02-28 |
| MedalOne Total Knee System (K244039) | Suzhou Microport Orthorecon Co., Ltd. | 2025-02-28 |
| Myomics (K241922) | Phantomics, Inc. | 2025-02-28 |
| Intravascular Extension Sets and Accessories (K242339) | Baxter Healthcare Corporation | 2025-02-28 |
| QIAstat-Dx GI Panel 2 Mini B (K250324) | QIAGEN GmbH | 2025-02-28 |
| MagDI System (MAG-02, DS-01) (K243359) | Gt Metabolic Solutions, Inc. | 2025-02-28 |
| Seclusion Catheter (K243436) | Basis Medical | 2025-02-28 |
| FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) (K243874) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-02-28 |
| Durex Polyisoprene Condom (K241617) | Rb Health (Us), LLC | 2025-02-28 |
| DYNAMIS™ SI Screw System (K243565) | Promethean Restorative, LLC | 2025-02-28 |
| ChestView US (K241620) | Gleamer Sas | 2025-02-27 |
| XOD Diathermia Radiofrequency Device (K242175) | Xod, Inc. | 2025-02-27 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (K243704) | Brosmed Medical Co., Ltd. | 2025-02-27 |
| VADER® Pedicle System and VADER®one Pedicle System (K242900) | Icotec AG | 2025-02-27 |
| Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (K242128) | Xaga Surgical | 2025-02-27 |
| microINR System (K243543) | Iline Microsystems, S.L. | 2025-02-27 |
| The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (K243738) | Thermo Fisher Scientific | 2025-02-27 |
| CastleLoc Pectus Bar System (K243357) | L&K BIOMED Co., Ltd. | 2025-02-27 |
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| PIVO™ Pro Needle-free Blood Collection Device (K241586) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 |
| EzVu Visual Vasopressor injector (EV-19) (K241595) | Veol Medical Technologies Pvt , Ltd. | 2025-02-27 |
| Rotium (K250021) | Nanofiber Solutions, LLC | 2025-02-27 |
| AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (K244043) | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-27 |
| Aventus Thrombectomy System (K250202) | Inquis Medical | 2025-02-26 |
| Ventripoint Medical System Plus (VMS+) 4.0 (K241222) | Ventripoint Diagnostics , Ltd. | 2025-02-26 |
| Medline Level 4 Surgical Gown with Breathable Sleeves (K242844) | Medline Industries, LP | 2025-02-26 |
| BonVie+ (K250346) | Elute, Inc. | 2025-02-26 |
| Vasoview Hemopro 3 Power Supply (K243918) | Maquet Cardiovascular, LLC | 2025-02-26 |
| Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) (K244031) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) (K241576) | Infraredx, Inc. | 2025-02-26 |
| DEKA LOTUS (K250281) | El.En S.P.A. | 2025-02-26 |
| pilot TLS (K241587) | Vygon Corporation | 2025-02-26 |
| aiCockpit AI Viewer (K241546) | Fovia, Inc. | 2025-02-26 |
| Heel Incision Safety Lancet (SteriHeel 2) (K244036) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012) | Perfuze, Ltd. | 2025-02-26 |
| BruxZir® Esthetic NOW (K250223) | Prismatik Dentalcraft, Inc. | 2025-02-25 |
| Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (K233963) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-02-25 |
| Loss of Pulse Detection (K242967) | Fitbit | 2025-02-25 |
| JLK-AILink (K250348) | JLK, Inc. | 2025-02-25 |
| ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) (K243276) | Ethicon Endo-Surgery, LLC | 2025-02-25 |
| EMS (FlexPulse, MagnaCore, Magnetika) (K241601) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2025-02-25 |
| WasherCap™ Fixation System (K250238) | Abanza Tecnomed S.L | 2025-02-25 |
| 3DXR (K243446) | GE Medical Systems SCS | 2025-02-25 |
| ART-Plan+ (v.3.0.0) (K242822) | Therapanacea Sas | 2025-02-25 |
| APRO 70 Swift Catheter and Alembic Aspiration Tubing (K243287) | Alembic, LLC | 2025-02-24 |
| SD Implant System (K241703) | Arum Dentistry Co., Ltd. | 2025-02-24 |
| ExamVue Apex (K244010) | Jpi Healthcare Co, Ltd. | 2025-02-24 |
| Sterilization Package/Reel (K241565) | Anqing Clean Dental Instrument Technology Co., Ltd. | 2025-02-24 |
| Control-IQ+ technology (K243823) | Tandem Diabetes Care, Inc. | 2025-02-24 |
| OncoStudio (OS-01) (K242994) | Oncosoft. Co., Ltd. | 2025-02-24 |
| Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs (K243959) | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2025-02-24 |
| Ulthera® System (K243035) | Ulthera, Inc. | 2025-02-24 |
| Sonio Suspect (K243614) | Sonio | 2025-02-21 |
| Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (K241555) | Rti Surgical, Inc. | 2025-02-21 |
| Synthetic Bone Graft Particulate (K241186) | Shenzhen Dazhou Medical Technology Co., Ltd. | 2025-02-21 |