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
DentalMonitoring
Dental Monitoring Sas
EarliPoint
Earlitec Diagnostics, Inc.
StimTrial Neuromodulation System
Bioventus, LLC
VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync B
Vivachek Biotech (Hangzhou) Co., Ltd.
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems Corporation
Fine Osteotomy
Bodycad Laboratories, Inc.
T3 Platform software
Etiometry, Inc.
Fibrillar Collagen Wound Dressing
Collagen Matrix, Inc.
FluoroDose Varnish
Centrix, Inc.
VITEK MS PRIME
bioMerieux, Inc.
Flowflex Plus RSV + Flu A/B + COVID Home Test
ACON Laboratories, Inc.
UltraSight AI Guidance
Ultrasight, Inc.
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
Sorin Group Italia S.R.L.
Tigertriever 13 Ultra Revascularization Device
Rapid Medical Ltd.
Prana System
Prana Surgical
Claritag Advanced
Dgi Technologies
ZYLOX Hippo PTA Balloon Dilatation Catheter
Zylox Medtech Co., Ltd.
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
BIOCERAM AZUL® HEAD
Kyocera Corporation
HeartFocus
Deski
FemVue® Controlled Saline-Air Device (FSA-300)
Femasys, Inc.
reVive Light Therapy Essentials
Led Technologies, Inc.
Model 9100 PFT/DICO
Vitalograph Ireland, Ltd.
BruxZir® Esthetic NOW
Prismatik Dentalcraft, Inc.
Electromagnetic Stimulation Systems
Shanghai Apolo Medical Technology Co., Ltd.
Benchmark BMX96 Access System
Penumbra, Inc.
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
Convatec, Inc.
Aura Wave
Aura Wellness, LLC
Arthrex FiberTak Suture Anchor
Arthrex, Inc.
Expandable Titanium PLIF/TLIF System
Spectrum Spine, Inc.
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