| K242676 — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | Phenox Limited Feb 28, 2025 |
| K250324 — QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH Feb 28, 2025 |
| K243359 — MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. Feb 28, 2025 |
| K243730 — Xpert C. difficile/Epi | Cepheid® Feb 28, 2025 |
| K244039 — MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. Feb 28, 2025 |
| K241550 — Gelweave Vascular Prostheses | Vascutek, Ltd. Feb 27, 2025 |
| K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific Feb 27, 2025 |
| K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. Feb 27, 2025 |
| K243543 — microINR System | Iline Microsystems, S.L. Feb 27, 2025 |
| K243357 — CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. Feb 27, 2025 |
| K241595 — EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt , Ltd. Feb 27, 2025 |
| K241620 — ChestView US | Gleamer Sas Feb 27, 2025 |
| K241586 — PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. Feb 27, 2025 |
| K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. Feb 27, 2025 |
| K242900 — VADER® Pedicle System and VADER®one Pedicle System | Icotec AG Feb 27, 2025 |
| K242128 — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical Feb 27, 2025 |
| K250021 — Rotium | Nanofiber Solutions, LLC Feb 27, 2025 |
| K242175 — XOD Diathermia Radiofrequency Device | Xod, Inc. Feb 27, 2025 |
| K244036 — Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. Feb 26, 2025 |
| K241222 — Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics , Ltd. Feb 26, 2025 |
| K250202 — Aventus Thrombectomy System | Inquis Medical Feb 26, 2025 |
| K250346 — BonVie+ | Elute, Inc. Feb 26, 2025 |
| K241576 — Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Infraredx, Inc. Feb 26, 2025 |
| K250012 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. Feb 26, 2025 |
| K243918 — Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular, LLC Feb 26, 2025 |
| K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | SteriLance Medical (Suzhou), Inc. Feb 26, 2025 |
| K241546 — aiCockpit AI Viewer | Fovia, Inc. Feb 26, 2025 |
| K250281 — DEKA LOTUS | El.En S.P.A. Feb 26, 2025 |
| K241587 — pilot TLS | Vygon Corporation Feb 26, 2025 |
| K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP Feb 26, 2025 |
| K243446 — 3DXR | GE Medical Systems SCS Feb 25, 2025 |
| K241601 — EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) Feb 25, 2025 |
| K242822 — ART-Plan+ (v.3.0.0) | Therapanacea Sas Feb 25, 2025 |
| K233963 — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. Feb 25, 2025 |
| K250223 — BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. Feb 25, 2025 |
| K250348 — JLK-AILink | JLK, Inc. Feb 25, 2025 |
| K243276 — 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) | Ethicon Endo-Surgery, LLC Feb 25, 2025 |
| K250238 — WasherCap Fixation System | Abanza Tecnomed S.L Feb 25, 2025 |
| K242967 — Loss of Pulse Detection | Fitbit Feb 25, 2025 |
| K244010 — ExamVue Apex | Jpi Healthcare Co, Ltd. Feb 24, 2025 |
| K241703 — SD Implant System | Arum Dentistry Co., Ltd. Feb 24, 2025 |
| K243287 — APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC Feb 24, 2025 |
| K243823 — Control-IQ+ technology | Tandem Diabetes Care, Inc. Feb 24, 2025 |
| K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. Feb 24, 2025 |
| K241565 — Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. Feb 24, 2025 |
| K242994 — OncoStudio (OS-01) | Oncosoft. Co., Ltd. Feb 24, 2025 |
| K243035 — Ulthera® System | Ulthera, Inc. Feb 24, 2025 |
| K243278 — Custom Abutments | Institut Straumann AG Feb 21, 2025 |
| K242607 — ScanDiags Ortho L-Spine MR-Q | Scandiags AG Feb 21, 2025 |
| K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV Feb 21, 2025 |