510(k) Clearances — Page 103
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241391 — Straumann® PURE Ceramic Implants | Institut Straumann AG Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242848 — Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242025 — Elos Accurate® Hybrid Base | Elos Medtech Pinol A/S Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242630 — Aerin Console | Aerin Medical, Inc. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242511 — V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231216 — POTENZA | Jeisys Medical, Inc. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241505 — DRX-Revolution Mobile X-ray System | Carestream Health, Inc. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242508 — Verily Numetric Retinal Camera | Verily Life Sciences, LLC Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242729 — AutoContour (Model RADAC V4) | Radformation, Inc. 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) |
| K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Edwards Lifesciences 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) |
| 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) |
| K242304 — RED | Neuraxis, Inc. 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) |
| K241567 — MC2 Portable X-ray System | Oxos Medical 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) |
| K240561 — Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. 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) |
| K241543 — DrAid for Liver Segmentation | Vinbrain Joint Stock Company 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) |
| 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) |
| K240840 — Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| K241674 — OSTEOPAL® V | Heraeus Medical GmbH 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) |
| 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) |
| K243463 — BIOFIRE FILMARRAY Tropical Fever Panel | Biofire Diagnostics, LLC (Biomerieux) Thu Dec 05 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) |
| 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) |
| K243435 — Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |