| K241785 — StarFormer (M008-3T) | Fotona D.O.O. Mar 27, 2025 |
| K242745 — AI-Rad Companion Organs RT | Siemens Healthcare GmbH Mar 27, 2025 |
| K243995 — Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. Mar 26, 2025 |
| K243831 — Rayvolve LN | AZmed Mar 26, 2025 |
| K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. Mar 26, 2025 |
| K250134 — Power Wheelchair (YH-E6011,YH-E6013A) | Ningbo Youhuan Automation Technology Co., Ltd. Mar 26, 2025 |
| K250542 — AC3 Range Intra-Aortic Balloon Pump | Arrow International, LLC Mar 26, 2025 |
| K250194 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) | Shenzhen Ulike Smart Electronics Co., Ltd. Mar 26, 2025 |
| K240189 — NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, Mar 26, 2025 |
| K242669 — SnapshotGLO (KB100) | Kent Imaging, Inc. Mar 26, 2025 |
| K243891 — EarliPoint System | Earlitec Diagnostics Mar 26, 2025 |
| K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life Mar 26, 2025 |
| K244003 — Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Mar 26, 2025 |
| K250668 — Aventus Thrombectomy System (IM-2100) | Inquis Medical Mar 25, 2025 |
| K250225 — Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. Mar 25, 2025 |
| K241921 — Alinity m BKV | Abbott Molecular, Inc. Mar 24, 2025 |
| K250603 — AxTiHA® Stand-Alone ALIF System | Innovasis Mar 24, 2025 |
| K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments Mar 24, 2025 |
| K250182 — Innovasis Navigation Instruments | Innovasis, Inc. Mar 24, 2025 |
| K242356 — TIDAL Fusion Cage System | Restor3D, Inc. Mar 24, 2025 |
| K243991 — Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. Mar 24, 2025 |
| K243865 — AERO MIS Facet Fusion System | Aurora Spine Mar 24, 2025 |
| K243642 — UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. Mar 24, 2025 |
| K243052 — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) | Bright Uro, Inc. Mar 24, 2025 |
| K250013 — VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) | Control Medical Technology, Inc. / Dba Ventiv Scientific Mar 24, 2025 |
| K242893 — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited Mar 24, 2025 |
| K250125 — LMNT O2 | Xplr , Ltd. Mar 24, 2025 |
| K243525 — SonoTAP and SonoTAP II | PAJUNK GmbH Medizintechnologie Mar 24, 2025 |
| K242564 — Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | Prismatik Dentalcraft, Inc. Mar 21, 2025 |
| K250517 — Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 | Boston Scientific Corporation Mar 21, 2025 |
| K243032 — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Mar 21, 2025 |
| K243958 — Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments Mar 21, 2025 |
| K243630 — Medical Laser System Incanto / Evoline Platinum /Evoline | Solar LS Cjsc Mar 21, 2025 |
| K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | Stryker Neurovascular Mar 21, 2025 |
| K242888 — Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Mar 21, 2025 |
| K241833 — V-GRAD | Vitromed GmbH Mar 21, 2025 |
| K250556 — Porous Biologic Scaffold | Ventris Medical Mar 21, 2025 |
| K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC Mar 21, 2025 |
| K243185 — REMI Remote EEG Monitoring System | Epitel Mar 21, 2025 |
| K250403 — Catamaran SI Joint Fusion System | Tenon Medical Mar 21, 2025 |
| K241065 — ChecQ (AC100) | Dentis Co., Ltd. Mar 21, 2025 |
| K243649 — BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson And Company Mar 21, 2025 |
| K242107 — CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. Mar 21, 2025 |
| K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC Mar 21, 2025 |
| K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC Mar 21, 2025 |
| K243808 — Rayvolve PTX-PE | AZmed Mar 21, 2025 |
| K243451 — FiAPC plus probes | Erbe Elektromedizin GmbH Mar 21, 2025 |
| K243980 — ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited Mar 21, 2025 |
| K250513 — IntelliSep Test (CV-ICG-048) | Cytovale, Inc. Mar 21, 2025 |
| K250106 — Signos Glucose Monitoring System | Signos, Inc. Mar 21, 2025 |