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
Exablate Prostate System
Insightec, Inc.
VASSALLO GT Crossing14
Filmec Co. , Ltd.
ARIX Humerus System
Jeil Medical Corporation
Levator Elite (Model LE9011)
Shenzhen Dongdixin Technology Co., Ltd.
Disposable Grasping Forceps FG-52D/FG-54D
Olympus Medical Systems Corp.
AF Laser
ShenB Co., Ltd.
Liberant RX Aspiration Catheter
Medtronic Interventional Vascular, Inc.
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
Medtronic, Inc.
Pantera Pro; Pantera LEO
Biotronik, Inc.
Advanced Bone Plate
Double Medical Technology, Inc.
Disposable Blood Pressure Cuff
Wenzhou Xikang Medical Instruments Co., Ltd.
Tinnitogram Signal Generator
Goldenear Company, Inc.
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast
O&M Halyard, Inc.
MuscleView
Springbok, Inc.
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Siemens Medical Solutions USA, Inc.
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
Orthofix Srl
Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
Verruca-Freeze H Plus
Cryosurgery, Inc.
Therapy US
Dmc Importação E Exportação DE Equipamentos Ltda
Zenition 30
Philips Medical Systems Nederland B.V.
Theracor
Stimlabs, LLC
trophon2
Nanosonics
Architect CMV IgG
Abbott Laboratories
EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ
Samsung Medison Co., Ltd.
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
OsteoCentric Technologies
ECHELON Synergy V10.0
FUJIFILM Healthcare Americas Corporation
PELNAC Wound Matrix
Gunze Limited
PrimmaArt
Dentscare Ltda
Navient Image Guide Navigation System (955-NC-NC), Cranial
Claronav
NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenari
Hycor Biomedical
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