| K250118 — Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation Jun 4, 2025 |
| K243368 — Montblanc Plate System | Medifield Medical Co., Ltd. Jun 4, 2025 |
| K250879 — Paradigm System | Proprio, Inc. Jun 4, 2025 |
| K241433 — EVE Synergy (EVE-20M) | Weero Co., Ltd. Jun 4, 2025 |
| K251433 — 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 Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | Surgify Medical OY Jun 4, 2025 |
| K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. Jun 4, 2025 |
| K251397 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | Philips Medical Systems Nederland B.V. Jun 4, 2025 |
| K242712 — LubriZenzs | Sk Zen, LLC Jun 4, 2025 |
| K240788 — Ultrasound Stimulator | Jkh Health Co., Ltd. Jun 4, 2025 |
| K243499 — NG-Test® CTX-M MULTI | Ng Biotech Jun 4, 2025 |
| K243843 — Tendon Protect (50242) | Kerecis Limited Jun 4, 2025 |
| K250682 — BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | Becton Dickinson Infusion Therapy Systems, Inc. Jun 3, 2025 |
| K242897 — Partial Flex | Clemde SA DE CV Jun 3, 2025 |
| K243205 — EVAC | Phasor Health, LLC Jun 3, 2025 |
| K250657 — gi2000 Electrosurgical Generator | Cintron Medical Corporation Jun 3, 2025 |
| K250529 — Globe Introducer (601-01001) | Kardium, Inc. Jun 3, 2025 |
| K243948 — Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC Jun 3, 2025 |
| K250598 — Endoform Reconstructive Template - PLGA | Aroa Biosurgery , Ltd. Jun 3, 2025 |
| K251127 — PENTAX Medical Video Processor (EPK-i8020c) | Pentax Of America, Inc. Jun 3, 2025 |
| K243796 — GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] | Glove One, LLC Jun 3, 2025 |
| K250001 — Patriot SI Implant System | Spinal Simplicity, LLC Jun 3, 2025 |
| K251035 — DISINTEK PA Test Strips | Serim Research Jun 3, 2025 |
| K243382 — RZ Resectoscope System | Rz Medizintechnik GmbH Jun 3, 2025 |
| K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. Jun 2, 2025 |
| K251335 — Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC Jun 2, 2025 |
| K250452 — CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | MacroLux Medical Technology Co., Ltd. Jun 2, 2025 |
| K250844 — PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop | Science & Bio Materials (S.B.M.) Sas Jun 2, 2025 |
| K250410 — GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. Jun 2, 2025 |
| K251376 — LimFlow ARC | LimFlow, Inc. May 31, 2025 |
| K242725 — Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. May 30, 2025 |
| K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) | Maquet Cardiovascular, LLC May 30, 2025 |
| K243654 — DentalJect | Vapocoolshot, Inc. May 30, 2025 |
| K250957 — Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | Olympus Medical Systems Corporation May 30, 2025 |
| K250195 — MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) | Matelaser, Inc. May 30, 2025 |
| K250078 — Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | Mindset Medical, Inc. May 30, 2025 |
| K242830 — LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. May 30, 2025 |
| K242926 — XBody Go USA, XBody Pro USA | Xbody Hungary Kft. May 30, 2025 |
| K242635 — Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. May 30, 2025 |
| DEN240047 — Allix5 | Clairity, Inc. May 30, 2025 |
| K250024 — TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. May 30, 2025 |
| K250637 — VCFix Spinal System | Amber Implants May 30, 2025 |
| K243005 — AudaxCeph Cephalogram Analysis Software | Audax D.O.O. May 30, 2025 |
| K241313 — OHC COVID-19 Antigen Self Test | Osang, LLC May 30, 2025 |
| K242751 — ARIX Pectus Bar System | Jeil Medical Corporation May 30, 2025 |
| K250365 — Motif Aura Glow breast pump (Model Motif Aura Glow) | Shenzhen TPH Technology Co., Ltd. May 30, 2025 |
| K250581 — KALA Red Light Face Mask (KALA-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. May 30, 2025 |
| K250150 — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | Sorin Group Italia S.R.L. May 30, 2025 |
| K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce | Owens & Minor (O&M) Halyard, Inc. May 30, 2025 |
| K251406 — BriefCase-Triage | Aidoc Medical , Ltd. May 30, 2025 |
| K251063 — TekBrace Solo Soft Tissue Reinforcement Device | Theramicro May 30, 2025 |