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
Revi System
Bluewind Medical , Ltd.
CONDUIT ATP Inserters
Enztec Limited
RAYMO Mobile X-ray System (Model: RAYMO)
DRGEM Corporation
ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer
Argon Medical Devices, Inc.
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire G
Olympus Medical Systems Corp.
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
Rb Health (Us)
Versalock Rib and Sternum Plates System
GM Dos Reis Industria e Comercio Ltda.
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy Sys
Neuronetics, Inc.
NEAT 001
Brain Electrophysiology Laboratory Company, LLC
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyes
T.A.G. Medical Products Corporation, Ltd.
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
Helena Laboratories, Corp.
Fitness Belt (Model: KLT-07)
Shenzhen Kelutongda Industrial Co., Ltd.
HexaPLUS S OneDrill Implant System
Osseofuse International, Inc.
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
Sb-Kawasumi Laboratories, Inc.
Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd.
Accure Laser System
Accure Acne, Inc.
ChM 4.5mm Cortical screws
Chm Sp. Z O.O.
Qraycam PRO
AIOBIO Co., Ltd.
Digital Thermometer, Model: DT007, DT008
Guangzhou Berrcom Medical Device Co., Ltd.
NEONA 1.5T MRI System
Time Medical Limited
Cohitech Cottonlock Tampons with Reusable Applicator
Cotton High Tech S.L.
Hammerdesis Interphalangeal Fusion System
Intelivation
LifeStyles® HydraFeel Natural Rubber Latex Condom
Suretex Limited
Medical Diode Laser (M2-GK)
Wuhan Pioon Technology Co., Ltd.
NAVOYCDS
Algodx AB
Geistlich Wound Matrix PLUS
Geistlich Pharma AG
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs
Shandong Blue Sail Health Technology Co., Ltd.
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Every Cycle Reusable Tampon Applicator
Cycle, LLC
NUVENTUS NV.C Prosthetic Components
Infinitum Eta, Ltd.
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