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
FairFix Adjustable Button System
Medacta International S.A.
MDx-Chex for BCID2
Streck, Inc.
EchoPAC Software Only / EchoPAC Plug-in (v211)
GE Medical Systems Ultrasound and Primary Care Diagnostics
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Route 92 Medical, Inc.
TOSAMA Reusable Applicator
Tosama, D.O.O.
Ascension Silicone MCP; Ascension Silicone PIP
Ascension Orthopedics, Inc.
MR Diffusion Perfusion Mismatch V1.0
Olea Medical
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
Boston Scientific Corporation
zirkon; structure; LFU shades, stains and glazes
Estetic Ceram AG
Neonav ECG Tip Location System
Navi Medical Technologies
T-FIX 3DSI Joint Fusion System
Cutting Edge Spine, LLC
Evo® sEEG System
Neuroone Medical Technologies Corp.
Glovmaster Nitrile Examination Glove Powder Free
Glovmaster Sdn. Bhd.
AnyPlus II Spinal Fixation System
GS Medical Co., Ltd.
Protect-It Custom Fit Dental Guard
Doc Brands, Inc.
RadiForce MX317W-PA
Eizo Corporation
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
Srirungruang Global Co., Ltd.
iLet Dosing Decision Software
Beta Bionics, Inc.
EasyScreen Gastrointestinal Parasite Detection Kit
Genetic Signatures Limited
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
Biomet, Inc.
Medi Lift Essential Eye Mask
Ya-Man, Ltd.
SofWave System
Sofwave Medical, Ltd.
Rapid Aortic Measurements
Ischemaview, Inc.
InfaTherm Disposable Infant Warming Mattress
International Biomedical
Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer
Cardicare Company, Ltd.
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
Wuxi Jiajian Medical Instrument Co., Ltd.
XERF
Lutronic Corporation
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straigh
Boston Scientific Corp
Viz Subdural+, Viz SUBDURAL PLUS
Viz. Ai, Inc.
Brainance MD
Advantis Medical Imaging Single Member P.C.
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