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
Fibresolve (with PCCP)
Imvaria, Inc.
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
Efofex, Inc.
FLUME catheter
The Flume Catheter Company, Ltd.
BD Vacutainer® K2 EDTA Blood Collection Tubes
Becton, Dickinson and Company
I.V. Administration Set, I.V. Extension Set
Bq Plus Medical Co., Ltd.
Keikku Electronic stethoscope
Lapsi Health Holding B.V.
uWS-Angio Pro
Shanghai United Imaging Healthcare Co., Ltd.
aprevo® anterior lumbar interbody fusion device with interfixation
Carlsmed, Inc.
Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-0
Jiangsu Bangbang Intelligent Technology Co., Ltd.
Collagen Dura Regeneration Membrane - Repair
Collagen Matrix, Inc.
INSULCLOCK® v2.0 PRO
Insulcloud S.L.
S.I.N. Dental Implant System
S.I.N. Implant System Ltda
VyLink Spinal Screw System
Vy Spine, LLC
G Surgical Marksman MIS System
G Surgical, LLC
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multic
Techno-Path Manufacturing , Ltd.
ANDORATE® Valve Kit
Ga Health Company Limited
BruxZir Incisal Coloring Liquid
Prismatik Dentalcraft, Inc.
Diode Laser Therapy Systems (DL612A)
Hebei Zollvan Medical Technology Co., Ltd.
Tranquil-C Interbody System
Nexus Spine, LLC
Trivicta Hip Stem
Ortho Development Corp.
Advanced Cryo Wart Remover
Medical Brands Laboratories B.V.
AC Cream - Conductive paste
Spes Medica Srl
Sol-M Luer Lock Syringe
Sol-Millennium Medical, Inc.
Air Compression Massager (Model LF-FT003)
Wenzhou Lingfeng Electronic Technology Co., Ltd.
TMC Implant Fixation System
Treace Medical Concepts, Inc.
Terran NM-101
Terran Biosciences, Inc.
myray ProXIma X6
Cefla S.C.
Nd:Yag Laser Therapy Systems
Beijing Unt Technology Co., Ltd.
Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
Medline Industries, LP
AccuMeasure System
RQMIS, Inc.
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