| 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 |
| K251209 — Medical Monitor (32HS710S) | Lg Electronics.Inc Jun 12, 2025 |
| K251193 — Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | Medtronic Sofamor Danek, Inc. Jun 12, 2025 |
| K243683 — Deka Bluebeam | El.En S.P.A. Jun 12, 2025 |
| K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Biomérieux Jun 12, 2025 |
| K251279 — Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corporation Jun 12, 2025 |
| K243482 — Self-Forming Magnet (Flexagon) | GI Windows, Inc. Jun 11, 2025 |
| K251499 — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) | William Cook Europe Aps Jun 11, 2025 |
| K250584 — Rezum System | Boston Scientific Corporation Jun 11, 2025 |
| K250710 — Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. Jun 11, 2025 |
| K250646 — Impact PEEK Union Nail System | Nvision Biomedical Technologies Jun 11, 2025 |
| K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. Jun 11, 2025 |
| K240852 — da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. Jun 11, 2025 |
| K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) | Ambu A/S Jun 11, 2025 |
| K250933 — LORRAINE 2.5/3.5mm Distal Humerus System | Bonebridge AG Jun 11, 2025 |
| K250787 — Liberant Thrombectomy System | Medtronic, Ireland Jun 11, 2025 |
| K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation Jun 10, 2025 |
| K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm | Vitaltec Corporation Jun 10, 2025 |
| K243512 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation Jun 10, 2025 |
| K250010 — EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation Jun 10, 2025 |
| K250735 — Dental Barrier and Sleeves | Fomed Industries, Inc. Jun 10, 2025 |
| K250768 — Elecsys Anti-SARS-CoV-2 | Roche Diagnostics Jun 10, 2025 |
| K250354 — Viz Subdural+, Viz SUBDURAL PLUS | Viz. Ai, Inc. Jun 10, 2025 |