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
Inbentus Versatile
Iconic Solutions by Murcia, SL
BD Alaris Pump Epidural Infusion Set
Care Fusion
CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)
Medtronic Sofamor Danek USA, Inc.
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E
Bernhard Förster GmbH
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
Arthrex, Inc.
CapsoCam Plus (SV-3) Capsule Endoscopy System
CapsoVision, Inc.
Microcurrent Facial Device (CEC101, EEI101)
Shenzhen Dachi Communication Co., Ltd.
Disposable Medical Mask
Guangdong Lide Medical Technology Co., Ltd.
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
Prosidyan, Inc.
TalisMann Neuromodulation System
Bioventus, LLC
ShinEvac Smoke Evacuation Pencil
Shining World Health Care Co., Ltd.
PathBuilder Transseptal Needle
Shanghai Microport EP Medtech Co., Ltd.
e-Ortho Shoulder Software v1.1
FH Industrie
Wound Treatment System (VHT-200)
Vaporox, Inc.
DeepSkin (DEP100)
El Global Trade, Ltd.
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
Medexel Co.,Ltd
Intravascular Extension Sets and Accessories
Baxter Healthcare Corporation
Ceevra Reveal 3
Ceevra, Inc.
MonoStereo
Medicaltek Co., Ltd.
AutoContour (RADAC V6)
Radformation, Inc.
cryoICE cryoXT cryoablation probe (cryoXT)
AtriCure, Inc.
Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
Olympus Medical Systems Corporation
ARIX Pectus Bar System
Jeil Medical Corporation
Solar Lumbar Interbody Fusion System
Degen Medical, Inc.
Creatinine2
Abbott Ireland Diagnostics Division
S.I.N. Instrument Kits
S.I.N. - Sistema DE Implante Nacional S.A.
Coloring Liquid
Dongguan Xiangtong Co., Ltd.
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B
Transit Scientific, LLC
Comprehensive Humeral Fracture Positioning Sleeves
Biomet, Inc.
Tandry CMF Plate System
Microware Precision Co., Ltd.
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