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
SpyGlass Discover Balloon Dilation Catheter
Boston Scientific Corporation
Precice Ankle Salvage System
Nuvasive Specialized Orthopedics, Inc.
Pytheas Your Guided Trajectory
Pytheas Navigation Sas
Cryopush Cold Compression Device (A02-P-001)
Chengdu Cryo-Push Medical Technology Co.,Ltd
InstaFAN
Onepass Medical , Ltd.
StealthStation Cranial Software, v3.1.5 (9735585)
Medtronic Navigation, Inc.
Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
Suzhou Borage Medical Technology Co., Ltd.
Symani Surgical System
Medical Microinstruments, Inc.
Disposable Endoscopy Adapter Set
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
CREED Cannulated Screws
Glw, Inc.
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
Xelite Biomed , Ltd.
3-Ply Disposable Medical Mask
Wealth Lead Industrial Limited
AirKEE P900
Healkee Medical Pte, Ltd.
MICOR 700 with Auto I/A
Carl Zeiss Meditec Cataract Technology, Inc.
CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test
CorDx, Inc.
Pectus Blu System
Biomet Microfixation
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical G
Dukal Corporation
TriMed Compression Screws
TriMed, Inc.
Tecomet Global Unite Short Stem Instrumentation
Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories, Inc.
BD Nano 2nd Gen Pen Needle
Becton, Dickinson and Company
17HQ701G-B
Lg Electronics.Inc
BriefCase
Aidoc Medical , Ltd.
T-Line Hernia Mesh
Deep Blue Medical Advances, Inc.
VEA Align; spineEOS
Eos Imaging
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
Medtronic, Inc.
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
Sutter Medizintechnik GmbH
Stratum® Ankle Fusion Plating System
Nextremity Solutions, Inc.
Erchonia Zerona® VZ8
Erchonia Corporation
VALORY
Agfa N.V.
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