| K243957 — PICOALEX | Wontech Co., Ltd. Mar 12, 2025 |
| K243849 — 2430TCA with Xmaru W | Rayence Co., Ltd. Mar 12, 2025 |
| K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward Mar 12, 2025 |
| K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit | Biofire Defense, LLC Mar 12, 2025 |
| K243746 — Delphi Amplifier | Quantalx Neroscience Mar 12, 2025 |
| K250357 — RemunityPRO Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. Mar 11, 2025 |
| K242610 — 8mm Monopolar Curved Scissors (470179) | Iconocare Health Mar 11, 2025 |
| K241725 — Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. Mar 11, 2025 |
| K250424 — Arthrex TightRope Soft Button, RT | Arthrex, Inc. Mar 11, 2025 |
| K243029 — Origin TT Stem | Signature Orthopaedics Pty, Ltd. Mar 11, 2025 |
| K241562 — OutFlo Aortic Valve Dilatation Balloon Catheter | Disa Medinotec Mar 11, 2025 |
| K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | Stryker Instruments Mar 11, 2025 |
| K241944 — AGILON® XO Shoulder Replacement System | Implantcast GmbH Mar 10, 2025 |
| K243676 — Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery Mar 10, 2025 |
| K250188 — Wound Treatment System (VHT-200) | Vaporox, Inc. Mar 10, 2025 |
| K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. Mar 10, 2025 |
| K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) | Surgical Instrument Service And Savings, Inc. Mar 10, 2025 |
| K243839 — Alteon® HA Femoral Stems | Exactech, Inc. Mar 10, 2025 |
| K242338 — Cleerly LABS (v2.0) | Cleerly, Inc. Mar 7, 2025 |
| K243970 — Portable Wheelchair | Intradin (Shanghai) Machinery Co., Ltd. Mar 7, 2025 |
| K243515 — EpiWatch Monitoring System | Epiwatch, Inc. Mar 7, 2025 |
| K243798 — Orthex External Fixation System | OrthoPediatrics Corp. Mar 7, 2025 |
| K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. Mar 7, 2025 |
| K242510 — Geistlich Bio-Flow® | Geistlich Pharma AG Mar 7, 2025 |
| K243610 — APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG Mar 7, 2025 |
| K241799 — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C | Atmos Medizintechnik GmbH & Co. KG Mar 7, 2025 |
| K242914 — Op.n(TM) Navigation | Ecential Robotics Mar 7, 2025 |
| K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | Shanghai SeeGen Photoelectric Technology Co., Ltd. Mar 7, 2025 |
| K242642 — CuffTrek | Shanghai Longmann Tech Co., Ltd. Mar 7, 2025 |
| K242383 — Apex Locator | Shenzhen Rogin Medical Co., Ltd. Mar 7, 2025 |
| K242890 — SPINEART Navigation Instrument System | Spineart SA Mar 7, 2025 |
| K243801 — FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC Mar 7, 2025 |
| K241159 — Handbike Batec Electric | Batec Mobility, S.L. Mar 7, 2025 |
| K242207 — NOABLE LASER | Daeju Meditech Engineering Co., Ltd. Mar 7, 2025 |
| K241790 — XCELLARISPRO TWIST microneedling device | Dermaroller GmbH Mar 6, 2025 |
| K243331 — LVivo Seamless | Dia Imaging Analysis, Ltd. Mar 6, 2025 |
| K243578 — BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. Mar 6, 2025 |
| K250344 — BD Phoenix Automated Microbiology System | Becton, Dickinson And Company Mar 6, 2025 |
| K243871 — Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. Mar 6, 2025 |
| K243001 — Sterile Water USP and Sterile 0.9% Normal Saline USP | Laboratorios Biogalenic S.A. DE C.V. Mar 6, 2025 |
| K243724 — Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | Zimmer, Inc. Mar 6, 2025 |
| K241767 — Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. Mar 6, 2025 |
| K243842 — Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. Mar 6, 2025 |
| K243587 — PureLift GLOW | Xtreem Pulse, LLC Mar 6, 2025 |
| K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Well Lead Medical Co., Ltd. Mar 5, 2025 |
| K243751 — Mako Total Hip Application 5.0 | Mako Surgical Corp. Mar 5, 2025 |
| K242149 — NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. Mar 5, 2025 |
| K241770 — Prostate MR AI (VA10A) | Siemens Healthcare GmbH Mar 5, 2025 |
| K242190 — Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. Mar 5, 2025 |
| K242597 — CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. Mar 5, 2025 |