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
EyeCTester
Neuro-Eye Diagnostic Systems, LLC
AH Plus Endodontic Sealer
Dentsply Sirona, Inc.
Conductive Gel
Top-Rank Health Care Co., Ltd.
Optima Coil System
Balt USA, LLC
Artemis, Artemis TPO, Artemis MX
Eigen
Elecsys FT4 IV
Roche Diagnostics
EasyTouch Lancing Device
Stat Medical Devices
ENSO (Model 2)
Hinge Health, Inc.
QuickVision Ultimate rTMS
Brain Ultimate, Inc.
V-HEPES PLUS
Vitromed Langenfeld
Nitrile Examination Gloves
Niujian Technology Co., Ltd.
CorDx Tyfast COVID-19 Ag Rapid Test Rx
CorDx, Inc.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
Basic Medical Technology, Inc.
Treace Medical Concepts (TMC) Screw Fixation System
Treace Medical Concepts, Inc.
SmartIPL_NI System
Lumenis Be, Ltd.
MIVI Q Distal Access Catheter
Mivi Neuroscience, Inc.
EchoPAC Software Only / EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics
Osstem Abutment System
Osstem Implant Co., Ltd.
Ambra PACS
Dicom Grid Dba Ambra Health
BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-
MacroLux Medical Technology Co., Ltd.
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
Nexus Spine, LLC
AQUABEAM Robotic System (AB2000)
Procept Biorobotics
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
Sol-Millennium Medical, Inc.
FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
Fluoptics Sas (A Getinge Group Company}
PP Care Nitrile Examination Gloves
Eg Group Product and Services Co., Ltd.
S-Patch CardioAI
Wellysis Corp.
Pen Injector Needle 32.5
Terumo Corporation
Instrument Case P1340904
Cochlear
TipTraQ (TTQ001)
Pranaq Pte. , Ltd.
iFuse TORQ® Implant System
SI-BONE, Inc.
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