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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

Disposable Nitrile Examination Gloves

Shandong DS Safety Technology Co., Ltd.

Mini Superhawk Suture Anchor System

Responsive Arthroscopy, LLC

DVR® Crosslock Wrist Spanning Plate (131849181)

Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

neXus Ultrasonic Surgical Aspirator System

Misonix, Inc.

Supra Non-Stick Bipolar Forceps

Guenter Bissinger Medizintechnik GmbH

AutoChamber

HeartLung Corporation

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile

Shandong Intco Medical Products Co, Ltd.

Any-Paste

Mediclus Co., Ltd.

Cercare Medical Neurosuite

Cercare Medical A/S

Small Bone Nailing System

Skeletal Dynamics, Inc.

Erchonia GVL

Erchonia Corporation

Disposable Surgical Gown

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

Revolution External Plating System

New Standard Device Dba Metalogix

Reusable NIBP Cuff

Shenzhen Coreray Technology Co., Ltd.

Azer Scientific Universal Transport Medium

Azer Scientific, Inc.

Metal Cannulated Screw

Double Medical Technology, Inc.

MallyaG Injection Pen Adapter (MallyaG)

Biocorp Production

Pangea Utility Plating System, Pangea Platform

Stryker GmbH

VASSALLO GT EXT

Filmecc Co., Ltd.

Comprehensive® Convertible Glenoid - Vivacit-E Liner

Biomet Manufacturing Corp

Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS

Conformis, Inc.

ELEOS Limb Salvage System

Onkos Surgical

Pounce™ Thrombectomy System

Surmodics,Inc.

HWJECT Auto-disable syringe

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

i-STAT G cartridge with the i-STAT 1 System

Abbott Point of Care, Inc.

Vision

Softsmile, Inc.

Kisses Plus Implant System

Achimhai Medical Corporation

Ezra Flash

Ezra Ai, Inc.

Kyphoplasty Balloon Dilatation Catheters

Shanghai Lange Medtech Co., Ltd.

VerSys Cemented Revision/Calcar

Zimmer, Inc.

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