| 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 |
| K242996 — EndyMed PRO MAX | Endymed Medical, Ltd. Jun 10, 2025 |
| K250830 — LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | Shenzhen Sungrow Led Technology Co., Ltd. Jun 9, 2025 |
| K251500 — MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production Jun 9, 2025 |
| K251093 — Bonvadis® | Oneness Biotech Co., Ltd. Jun 9, 2025 |
| K250465 — CO2 Laser Machine (Lume) | Nanjing Bestview Laser S&T Co., Ltd. Jun 9, 2025 |
| K250746 — Magnetic Surgical System | Levita Magnetics International Corp Jun 7, 2025 |
| K250591 — Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. Jun 6, 2025 |
| K242759 — Geister K-Rex rongeurs | Geister Medizin Technik GmbH Jun 6, 2025 |
| K251452 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Steris Jun 6, 2025 |
| K251131 — Annex® 2 Adjacent Level System | Spine Wave, Inc. Jun 6, 2025 |
| K243550 — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & CO. KG Jun 6, 2025 |
| K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay | Luminex Corporation Jun 6, 2025 |
| K250109 — TYBR Collagen Gel | Tybr Health Jun 6, 2025 |
| K251525 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC Jun 6, 2025 |
| K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. Jun 6, 2025 |
| K243994 — Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. Jun 6, 2025 |
| K243694 — Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue | Mah Sing Healthcare Sdn. Bhd. Jun 6, 2025 |
| K242431 — Omnia Medical PsiF DNA System | Omnia Medical, LLC Jun 6, 2025 |
| K243456 — ONVOY Acetabular System | Globus Medical, Inc. Jun 6, 2025 |
| K250891 — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | Convatec Limited Jun 6, 2025 |
| K251042 — Light Therapy System (M500, L6) | Guangzhou Ahead Intelligent Technology Co., Ltd. Jun 6, 2025 |
| K251009 — Cirrus Resting State fMRI Software | Sora Neuroscience, Inc. Jun 6, 2025 |
| K243002 — MBA Biotech Implant System | MBA Biotech Co., Ltd. Jun 6, 2025 |
| K251283 — Once-Fil Flow | Mediclus Co., Ltd. Jun 6, 2025 |
| K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.R.L. Jun 6, 2025 |
| K250321 — GCI Sterilization Wrappers | George Courey, Inc. Jun 6, 2025 |
| K250722 — Nd: YAG Laser Therapy System (QN-1) | Hebei JT Medical Co., Ltd. Jun 6, 2025 |
| K240983 — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | Quanta System Spa Jun 6, 2025 |