510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Ion-L Navigated Instruments
SurGenTec, LLC
Glucose2
Abbott Ireland
Tempus ECG-Low EF
Tempus AI, Inc.
Explorer Air II
Surgvision GmbH
HFT150
Invent Medical Corporation
IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend
Alphatec Spine, Inc.
EVAC-MRI
Phasor Health, LLC
IGAR System (1001.A)
Insight Medbotics, Inc.
Automatic Digital Blood Pressure monitor (LD-526)
Honsun (Nantong) Co., Ltd.
Synq Software Version 1.3
Synaptive Medical, Inc.
FreeStyle Comfort (AS200 / FreeStyle Comfort)
Caire, Inc.
Bone Bolt System
University of Utah, Department of Orthopaedics
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
Roche Molecular Systems, Inc.
BreatheBand® (Model 1000)
Exemplar Medical, LLC
Aveta System 2.0
Meditrina, Inc.
Disposable Pre-calibrated Brain Biopsy Needle 2.0
PAJUNK GmbH Medizintechnologie
SpineUs System
Verdure Imaging
Disposable Automatically Retractable Safety Syringes (with detachable needle)
Shantou Wealy Medical Instrument Co.,Ltd
NOVA RESIN dual cure, self adhesive resin cement
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Hoffmann LRF System
Stryker GmbH
Capnostream35 Portable Respiratory Monitor (PM35MN)
Covidien, LLC
OutFlo Aortic Valve Dilatation Balloon Catheter
Disa Medinotec
Arthrex Knotless Mini TightRopes
Arthrex, Inc.
Optima Coil System (Optima Packing Coil System)
Balt USA, LLC
BioProtect Balloon Implant System
Bioprotect, Ltd.
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
Owens & Minor (O&M) Halyard, Inc.
14HQ901G-B
Lg Electronics.Inc
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
Shenzhen Bsx Technology Electronics Co., Ltd.
Montblanc Plate System
Medifield Medical Co., Ltd.
DEKA Loop
Deka Research and Development
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