| K244044 — PBC Separator with Selux AST System | Selux Diagnostics, Inc. Mar 28, 2025 |
| K242952 — INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH Mar 28, 2025 |
| K233953 — Makani Science Respiration Monitoring System | Makani Science, Inc. Mar 28, 2025 |
| K234067 — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Medphoton GmbH Mar 28, 2025 |
| K250596 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Mar 28, 2025 |
| K241927 — Synthes Graphic Case & Tray System | Synthes GmbH Mar 28, 2025 |
| K242022 — Access Toxo IgG | Beckman Coulter, Inc. Mar 28, 2025 |
| K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. Mar 28, 2025 |
| DEN240020 — Visby Medical Women's Sexual Health Test | Visby Medical, Inc. Mar 28, 2025 |
| K242201 — HyperSuture White/Green Extension Line | Threadstone, LLC Mar 27, 2025 |
| K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. Mar 27, 2025 |
| K243768 — iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. Mar 27, 2025 |
| K250092 — HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC Mar 27, 2025 |
| K241962 — Crossloop | Asahi Intecc Co., Ltd. Mar 27, 2025 |
| K243426 — Nurochek-Pro System | Headsafe Mfg Pty, Ltd. Mar 27, 2025 |
| K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | Access Vascular, Inc. Mar 27, 2025 |
| K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) | Scivita Medical Technology Co., Ltd. Mar 27, 2025 |
| K243038 — Salix Central | Artrya Limited Mar 27, 2025 |
| K250555 — MallyaD injection pen adapter (MallyaD) | Biocorp Production Mar 27, 2025 |
| K242745 — AI-Rad Companion Organs RT | Siemens Healthcare GmbH Mar 27, 2025 |
| K244046 — Edwards eSheath Optima introducer set | Edwards Lifesciences Mar 27, 2025 |
| K242919 — V5med Lung AI | V5Med, Inc. Mar 27, 2025 |
| K241785 — StarFormer (M008-3T) | Fotona D.O.O. Mar 27, 2025 |
| K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. Mar 27, 2025 |
| K240189 — NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, 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 |
| K250134 — Power Wheelchair (YH-E6011,YH-E6013A) | Ningbo Youhuan Automation Technology Co., Ltd. Mar 26, 2025 |
| K243995 — Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. Mar 26, 2025 |
| K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. Mar 26, 2025 |
| K243891 — EarliPoint System | Earlitec Diagnostics Mar 26, 2025 |
| K244003 — Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Mar 26, 2025 |
| K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life Mar 26, 2025 |
| K250542 — AC3 Range Intra-Aortic Balloon Pump | Arrow International, LLC Mar 26, 2025 |
| K242669 — SnapshotGLO (KB100) | Kent Imaging, Inc. Mar 26, 2025 |
| K243831 — Rayvolve LN | AZmed Mar 26, 2025 |
| K250225 — Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. Mar 25, 2025 |
| K250668 — Aventus Thrombectomy System (IM-2100) | Inquis Medical Mar 25, 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 |
| K250182 — Innovasis Navigation Instruments | Innovasis, 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 |
| K241921 — Alinity m BKV | Abbott Molecular, Inc. Mar 24, 2025 |
| K243525 — SonoTAP and SonoTAP II | PAJUNK GmbH Medizintechnologie Mar 24, 2025 |
| K250603 — AxTiHA® Stand-Alone ALIF System | Innovasis Mar 24, 2025 |
| K242356 — TIDAL Fusion Cage System | Restor3D, Inc. Mar 24, 2025 |
| K242893 — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited Mar 24, 2025 |
| K243991 — Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. Mar 24, 2025 |
| K250125 — LMNT O2 | Xplr , Ltd. Mar 24, 2025 |
| K243865 — AERO MIS Facet Fusion System | Aurora Spine Mar 24, 2025 |
| K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments Mar 24, 2025 |
| K243642 — UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. Mar 24, 2025 |