| K243618 — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge TO Life Jun 17, 2025 |
| K243666 — uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. Jun 17, 2025 |
| DEN240038 — Oxiplex® | Fziomed, Inc. Jun 17, 2025 |
| K250665 — SKR 3000 | Konica Minolta, Inc. Jun 17, 2025 |
| K243561 — Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation Jun 17, 2025 |
| K243003 — VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. Jun 17, 2025 |
| K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG Jun 17, 2025 |
| K250436 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. Jun 16, 2025 |
| K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. Jun 16, 2025 |
| K250443 — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Siemens Healthcare GmbH Jun 16, 2025 |
| K250685 — Methinks NCCT Stroke | Methinks Software, S.L Jun 16, 2025 |
| K250900 — EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. Jun 16, 2025 |
| K251617 — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. Jun 16, 2025 |
| K242870 — Access hsTnI | Beckman Coulter, Inc. Jun 16, 2025 |
| K244012 — Mosaic (V1.0.1) | Navier Medical Jun 16, 2025 |
| K242978 — Geo Abutment | Geomedi Co,., Ltd. Jun 16, 2025 |
| K243872 — BD Veritor System for SARS-CoV-2 | Becton, Dickinson And Company Jun 16, 2025 |
| K243036 — IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) | Bestway Plastic And Metal Products , Ltd. Jun 15, 2025 |
| K240795 — Withings ECG App | Withings Jun 15, 2025 |
| K242863 — Bioptimal Bipolar Pacing Catheter | Bioptimal International Pte. , Ltd. Jun 15, 2025 |
| K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | Inomed Medizintechnik GmbH Jun 13, 2025 |
| K250075 — Medtronic Stedi Extra Support Guidewire | Medtronic, Inc. Jun 13, 2025 |
| K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | Fresenius Medical Care Renal Therapies Group, LLC Jun 13, 2025 |
| K251166 — Mfinity Femoral System | Medacta International S.A. Jun 13, 2025 |
| K244017 — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation Jun 13, 2025 |
| K251485 — Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. Jun 13, 2025 |
| K250251 — Eleganz Fusion Screw System (Fusion Screw System) | Dev4 Jun 13, 2025 |
| K243633 — Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | Brainlab AG Jun 13, 2025 |
| K250273 — BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. Jun 13, 2025 |
| K250759 — 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. Jun 13, 2025 |
| K250469 — Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. Jun 13, 2025 |
| K243729 — Prismira | Lumos Labs, Inc. Jun 13, 2025 |
| K251189 — Aventus Thrombectomy System | Inquis Medical Jun 13, 2025 |
| K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) | Microvention Jun 13, 2025 |
| K250674 — Vessel Sealer Curved (480522) | Intuitive Surgical, Inc. Jun 13, 2025 |
| K250559 — GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio Jun 12, 2025 |
| K250936 — Q-Switched Nd:YAG Laser (SHE-LSP101-1) | Beijing Sano Laser S&T Development Co.,Ltd Jun 12, 2025 |
| K242872 — iDart Lyme IgM ImmunoBlot Kit | Id-Fish Technology, Inc. Jun 12, 2025 |
| K243234 — Second Opinion® CS | Pearl, Inc. Jun 12, 2025 |
| K251459 — OneLIF Interbody Fusion System | Novapproach Spine, LLC Jun 12, 2025 |
| K251154 — RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments | Ht Medical D.B.A. Xenix Medical Jun 12, 2025 |
| K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | Biocomposites, Ltd. Jun 12, 2025 |
| K243973 — FIX-L PEEK PLIF and T-PLIF System | Jeil Medical Corporation Jun 12, 2025 |
| K243608 — TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. Jun 12, 2025 |
| K250789 — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) Jun 12, 2025 |
| K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. Jun 12, 2025 |
| K250782 — Fractional CO2 Laser Machine | Zhengzhou PZ Laser Slim Technology Co., Ltd. Jun 12, 2025 |
| K251153 — Aurora | Ge Medical Systems Israel Jun 12, 2025 |
| DEN240032 — APO-Easy Genotyping kit | Firalis SA Jun 12, 2025 |
| K250826 — Multi M Series | Dmax Co., Ltd. Jun 12, 2025 |