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
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit
Centers for Disease Control and Prevention
Disposable Automatically Retractable Insulin Safety Syringe
Shantou Wealy Medical Instrument Co.,Ltd
NEONA 1.5T MRI System
Time Medical Limited
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Power
Lexington Medical, Inc.
Collagen P.I.N. (Percutaneous Induction Needling)
Induction Therapies, LLC
qXR-BT
Qure.Ai Technologies
Polyvinyl Alcohol Embolic Microspheres
Canyon Medical, Inc.
BTI Interna Narrow/Plus Dental Implant System UnicCa
B.T.I. Biotechnology Institute, Sl.
COPAL knee moulds
Heraeus Medical GmbH
HandPICO Fractional Laser Handpiece Tip
Vydence Medical
OxyLight 2.0
Raja Trading Company, Inc.
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Cannulated Screw and Kirschner (K wire) System
Orthonovis, Inc.
Maestro Platform
Moon Surgical
WatchPAT SW
Itamar Medical , Ltd.
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Mo
Circa Scientific, Inc.
MRidium 3870 MRI Infusion Pump System (3870)
Iradimed Corporation
SternaFuse Ti Fixation System
Fusion Innovations, LLC
BALTEUM - ONE Lumbar Plate System
Huvexel Co. , Ltd.
Prismira
Lumos Labs, Inc.
Clarius Ultrasound Scanner
Clarius Mobile Health Corp.
Tapestry Biointegrative Implant
Embody, Inc.
Ear Pressure Relief Device(Model:ER813B)
Ningbo Albert Novosino Co., Ltd.
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
Promimic AB
DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT
Depuy Ireland UC
EveryWare
Breas Medical AB
Revogene
Meridian Bioscience, Inc.
Pixie Skin Tag
Oystershell NV
TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
TriMed, Inc.
CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0
MacroLux Medical Technology Co., Ltd.
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