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
Seaman Pro/Seaman
Checkcells, Inc.
TENS & EMS Stimulator (MHD-1083)
Shenzhen Minghuangda Electronics Co., Ltd.
Scarlet® AL-T
Spineart SA
Promisemed Safety Huber Needles
Promisemed Hangzhou Meditech Co., Ltd.
LOCATOR® Angled Abutment
Zest Anchors, LLC
TECHFIT DISRP® System
Techfit Digital Surgery
Cystoscope System
Shenzhen HugeMed Medical Technical Development Co., Ltd.
VITROS Immunodiagnostic Products CK-MB Reagent Pack
Ortho Clinical Diagnostics
MasterX 800 Series
Medicatech USA
MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
Depuy Mitek
SternalPlate Expansion
Stryker Leibinger GmbH & Co KG
Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
Micro-Energy Medical Technology Co., Ltd.
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
Jiangsu Jichun Medical Devices Co., Ltd.
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconaz
bioMerieux, Inc.
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited
Modular Rotating Hinge Knee Systems and Compatible Components
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
G Surgical Marksman MIS System
G Surgical, LLC
Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)
Covidien
EndoSign® Cell collection device (ES-CYT-102)
Cyted Limited
AlloX2 Pro Tissue Expanders
Sientra, Inc.
LiquiBand XL
Advanced Medical Solutions Limited
Willow 24 Guidewire
Arbor Endovascular, LLC
MammoScreen® (4)
Therapixel
Mould Probe MR Safe
Varian Medical Systems, Inc.
Carriere® Motion Pro® Clear Bite Corrector
Ortho Organizers, Inc.
Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
Geistlich Pharma AG
EasyStat 300
Medica Corporation
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
Ovesco Endoscopy AG
Neurovascular Access System Family
Q'Apel Medical, Inc.
Superflow Prime Treatment System (ASP-1M)
Guangzhou Aimira Innovation Technology Co, Ltd.
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