| K244056 — DOC Band 3D | Cranial Technologies, Inc. Mar 17, 2025 |
| K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. Mar 17, 2025 |
| K250514 — UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. Mar 17, 2025 |
| K250498 — BPS Wrist Fracture System | Orthonovis, Inc. Mar 17, 2025 |
| K243862 — LVivo Software Application | Dia Imaging Analysis, Ltd. Mar 17, 2025 |
| K243867 — LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. Mar 17, 2025 |
| K243504 — MAIA (AHMACME001) | Centervue S.P.A. Mar 17, 2025 |
| K241975 — SERV MEDICAL CDSS | Serv Medical Pte., Ltd. Mar 17, 2025 |
| K243869 — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited Mar 17, 2025 |
| K250439 — Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca | Contract Medical International, GmbH Mar 16, 2025 |
| K242811 — BodyTom 64 | Neurologica Corporation, A Subsidiary Of Samsung Mar 14, 2025 |
| K243332 — Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. Mar 14, 2025 |
| K250079 — Ruby XL System | Penumbra, Inc. Mar 14, 2025 |
| K242121 — mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. Mar 14, 2025 |
| K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex, Inc. Mar 14, 2025 |
| K243529 — Solution Administration Sets | Baxter Healthcare Corporation Mar 14, 2025 |
| K242244 — Viewer+ | Lumea, Inc. Mar 14, 2025 |
| K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | Centers For Disease Control And Prevention Mar 14, 2025 |
| K241765 — PLANET Onco Dose (3.2) | Dosisoft SA Mar 14, 2025 |
| K241960 — DeepRESP | Nox Medical Ehf Mar 14, 2025 |
| K241816 — VerteGlide Spinal Growth Guidance System | OrthoPediatrics Corp. Mar 14, 2025 |
| K250025 — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. Mar 14, 2025 |
| K243838 — NEXXT MATRIXX® SI System | Nexxt Spine Mar 14, 2025 |
| K250401 — AION TempShield | Aion Biosystems, Inc. Mar 14, 2025 |
| K243353 — One-Fil Putty | Mediclus Co., Ltd. Mar 14, 2025 |
| K243599 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A Subsidiary Of Teleflex, Inc.) Mar 14, 2025 |
| K234012 — VITEK COMPACT PRO | bioMerieux, Inc. Mar 14, 2025 |
| K242323 — Maestro System (REF100) | Moon Surgical Mar 14, 2025 |
| K250091 — KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. Mar 14, 2025 |
| K242010 — Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) | Shenzhen Sanping Image Technology Co., Ltd. Mar 14, 2025 |
| K250267 — Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) | Kettenbach GmbH & Co. KG Mar 14, 2025 |
| K250255 — xvision Spine system | Augmedics, Ltd. Mar 13, 2025 |
| K250385 — Turbo-Elite Laser Atherectomy Catheter | Spectranetics Mar 13, 2025 |
| K243788 — IceCap product line | Bioserenity Medical Devices Group Mar 13, 2025 |
| K250088 — FlowTriever2 Catheter | Inari Medical, Inc. 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 |
| 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 |
| K242406 — SiOxC Cream | Sioxmed, LLC Mar 13, 2025 |
| K243735 — Ziehm Vision FD | Ziehm Imaging GmbH Mar 13, 2025 |
| K242997 — MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. Mar 13, 2025 |
| K250113 — neoLaser Laser Surgery Fibers | G.N.S Neolaser , Ltd. Mar 13, 2025 |
| K241811 — MedCAD® AccuStride System | Medcad Mar 13, 2025 |
| K250382 — Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. Mar 13, 2025 |
| K243993 — Photon Therapy Apparatus (BL-10) | Xemis Medical Technology (Shenzhen) Co., Ltd. Mar 13, 2025 |
| K243487 — CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. Mar 13, 2025 |
| K250605 — EVOL® ha Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC Mar 12, 2025 |
| K243763 — Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. Mar 12, 2025 |
| K250411 — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | Dannik, LLC Mar 12, 2025 |
| K243903 — RCT600 | Ray Co., Ltd. Mar 12, 2025 |
| K243783 — Walking rehabilitation training electric wheelchair (ZW518) | Shenzhen Zuowei Technology Co., Ltd. Mar 12, 2025 |