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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