| K242508 — Verily Numetric Retinal Camera | Verily Life Sciences, LLC Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243364 — TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242758 — Atrauman® Ag | Hartmann USA, Inc. Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240706 — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | Ganshorn Medizin Electronic GmbH Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240841 — Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240700 — HomeSleepTest (HST, HST REM+) | Somnomedics GmbH Sun Dec 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240461 — OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242824 — PTFE Guidewire | Lake Region Medical Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242687 — NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | AngioDynamics, Inc. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242304 — RED | Neuraxis, Inc. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241543 — DrAid for Liver Segmentation | Vinbrain Joint Stock Company Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241260 — ACTIFY Unicondylar Knee System | Globus Medical, Inc. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242950 — WallFlex Biliary PLUS RX Stent System | Boston Scientific Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243486 — SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | Abbott Molecular Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241923 — EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.Ai, Co., Ltd. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243073 — AnyPlus Navigated Instruments System | GS Medical Co., Ltd. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241989 — Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | Cercare Medical A/S Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240561 — Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240680 — CDM Insights | Oxford Brain Diagnostics, Ltd. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | Pentax of America, Inc. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240971 — 87 NeuGlide Catheter | Piraeus Medical Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240926 — PeekMed web | Peek Health, S.A. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241073 — DZ-Tabone Intervertebral Body Fusion Device | Shenzhen Dazhou Medical Technology Co., Ltd. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241946 — PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | Bard Peripheral Vascular, Inc. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241567 — MC2 Portable X-ray System | Oxos Medical Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242524 — SyMRI | Syntheticmr AB (Publ.) Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242645 — INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant | Project Chemistry, Inc. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240840 — Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242710 — Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241128 — TDM Plate and Screw System | Tdm Co., Ltd. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242703 — LW Pre-milled Abutment | Ossvis Co., Ltd. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243444 — BIOCERAM AZUL® HEAD | Kyocera Corporation Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243526 — MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241674 — OSTEOPAL® V | Heraeus Medical GmbH Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240025 — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | Ventana Medical Systems, Inc. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243463 — BIOFIRE FILMARRAY Tropical Fever Panel | Biofire Diagnostics, LLC (Biomerieux) Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243435 — Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242740 — Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co., Ltd. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243447 — Rapid Surgical Plan (RSP-SW-001) | Navbit Pty, Ltd. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242653 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL | Thermo Fisher Scientific Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242525 — iTOF® | Nerbio Medical Software Platforms, Inc. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242686 — Neodent Implant System | Jjgc Indústria E Comércia DE Materiais Dentários S.A. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242301 — Socrates 38 Catheter | Scientia Vascular, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242395 — Nanox.ARC | Nano-X Imaging , Ltd. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242831 — Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243180 — SSPC NXT Delivery Catheter | CenterPoint Systems, LLC Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243417 — RelieVRx | Appliedvr Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242348 — Locking Screw,CoCrMo | Double Medical Technology, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |