| K243332 — Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. Mar 14, 2025 |
| K243838 — NEXXT MATRIXX® SI System | Nexxt Spine Mar 14, 2025 |
| K250079 — Ruby XL System | Penumbra, Inc. Mar 14, 2025 |
| K242997 — MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. Mar 13, 2025 |
| K243735 — Ziehm Vision FD | Ziehm Imaging GmbH Mar 13, 2025 |
| K241811 — MedCAD® AccuStride System | Medcad Mar 13, 2025 |
| K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) | Surgify Medical OY Mar 13, 2025 |
| K250255 — xvision Spine system | Augmedics, Ltd. Mar 13, 2025 |
| K250113 — neoLaser Laser Surgery Fibers | G.N.S Neolaser , Ltd. Mar 13, 2025 |
| K250385 — Turbo-Elite Laser Atherectomy Catheter | Spectranetics Mar 13, 2025 |
| K244022 — 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | Boston Aesthetics, Inc. Mar 13, 2025 |
| K243487 — CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. Mar 13, 2025 |
| K243993 — Photon Therapy Apparatus (BL-10) | Xemis Medical Technology (Shenzhen) Co., Ltd. Mar 13, 2025 |
| K250088 — FlowTriever2 Catheter | Inari Medical, Inc. Mar 13, 2025 |
| K250382 — Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. Mar 13, 2025 |
| K243788 — IceCap product line | Bioserenity Medical Devices Group Mar 13, 2025 |
| K242406 — SiOxC Cream | Sioxmed, LLC Mar 13, 2025 |
| K243903 — RCT600 | Ray Co., Ltd. Mar 12, 2025 |
| K243957 — PICOALEX | Wontech Co., Ltd. Mar 12, 2025 |
| K243763 — Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. 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 |
| K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward Mar 12, 2025 |
| K243849 — 2430TCA with Xmaru W | Rayence Co., Ltd. Mar 12, 2025 |
| K243783 — Walking rehabilitation training electric wheelchair (ZW518) | Shenzhen Zuowei Technology Co., Ltd. Mar 12, 2025 |
| K250411 — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | Dannik, LLC Mar 12, 2025 |
| K250605 — EVOL® ha Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC Mar 12, 2025 |
| K243029 — Origin TT Stem | Signature Orthopaedics Pty, Ltd. Mar 11, 2025 |
| K250424 — Arthrex TightRope Soft Button, RT | Arthrex, Inc. Mar 11, 2025 |
| K250357 — RemunityPRO Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. Mar 11, 2025 |
| K241725 — Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. 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 |
| K242610 — 8mm Monopolar Curved Scissors (470179) | Iconocare Health Mar 11, 2025 |
| K243676 — Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery Mar 10, 2025 |
| K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. Mar 10, 2025 |
| K243839 — Alteon® HA Femoral Stems | Exactech, Inc. Mar 10, 2025 |
| K241944 — AGILON® XO Shoulder Replacement System | Implantcast GmbH Mar 10, 2025 |
| K250188 — Wound Treatment System (VHT-200) | Vaporox, 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 |
| K242890 — SPINEART Navigation Instrument System | Spineart SA Mar 7, 2025 |
| K243970 — Portable Wheelchair | Intradin (Shanghai) Machinery Co., Ltd. Mar 7, 2025 |
| K243798 — Orthex External Fixation System | OrthoPediatrics Corp. 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 |
| K243801 — FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC Mar 7, 2025 |
| K243610 — APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG Mar 7, 2025 |
| K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. Mar 7, 2025 |
| K242642 — CuffTrek | Shanghai Longmann Tech Co., Ltd. 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 |
| K242510 — Geistlich Bio-Flow® | Geistlich Pharma AG Mar 7, 2025 |