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
Jumong General
Sg Healthcare Co, Ltd.
NUVENTUS NV.C Surgical Cassette and Tray
Infinitum Eta, Ltd.
MAVERICK Mini External Fixation System
Smith & Nephew, Inc.
Chondral Quant
Siemens Medical Soultions USA, Inc.
SMARxT Tubing and Connectors
LivaNova USA, Inc.
WHOOP ECG (electrocardiogram) Feature (1.0)
Whoop., Inc.
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
Shenzhen Carejoy Technology Co., Ltd.
Persona the Personalized Knee System
Zimmer, Inc.
TECHFIT Diagnostic Models
Techfit Digital Surgery, Inc.
ANKYRAS
Mentice Spain S.L.
Grappler Suture Anchor System
Paragon 28, Inc.
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Osteonic Co., Ltd.
GMK Sphere Revision
Medacta International S.A.
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Olympus Medical Systems Corp.
ChecQ (AC100)
Dentis Co., Ltd.
NeuroStar Advanced Therapy System (All previously cleared models)
Neuronetics, Inc.
iCEM Universal Plus
Kulzer, LLC
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
bioMerieux, Inc.
OSSIOfiber Suture Anchor
OSSIO , Ltd.
2-Way 100% Silicone Cleartract Catheter
Silq Technologies Corporation
Avéli
Revelle Aesthetics, Inc.
Self-Forming Magnet (Flexagon Plus OTOLoc)
GI Windows, Inc.
Ceribell Brain Monitor Headband
Ceribell, Inc.
Ultrasound System 2300
Bk Medical Aps
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Immuno Concepts, N.A. , Ltd.
OPTOVISION Endoscopic Light Source Unit
Optosurgical, LLC
VOLT Proximal Humerus 3.5 Plating System
Synthes GmbH
S.I.N. Dental Implant System
S.I.N. Implant System Ltda
Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Ho
Yangzhou Medline Industry, Co., Ltd.
PINE Pedicle Screw System
Tdm Co., Ltd.
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