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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

Ruthless Spine RJB

Ruthless, LLC Dba Ruthless Spine

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Primed Medical Products, Inc.

EPIEN Dental Cleanser

Epien Medical, Inc.

TraumaGuard Intra-abdominal Pressure Sensing System

Sentinel Medical Technologies, LLC

The Circadia C300 System (C300)

Circadia Health, Inc.

Pain Therapy Device(Model: P.T.S-X)

Guangzhou Xinbo Electronic Co., Ltd.

AllPEP

Enchant Tek Co. , Ltd.

WatchPAT400 (WP400)

Itamar Medical , Ltd.

Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

Zhuhai Wesee Meditech Co., Ltd.

HemosIL Chromogenic Factor IX

Instrumentation Laboratory Company

Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

Stryker GmbH

Protective Gown AAMI Level 4

Kenpax International Limited

URIS Long Implant & Abutments

Truabutment, Inc.

Digital Thermometer

Wenzhou Yosun Medical Technology Co.,Ltd

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

Fujifilm Medwork GmbH

STIMPOD NMS450 Nerve Stimulator

Xavant Technology (Pty), Ltd.

Luvis Chair (LC700C)

Dentis Co., Ltd.

Eco Abutment, Multiunit Abutment

Dio Corporation

GORE® ENFORM Biomaterial

W. L. Gore and Associates, Inc.

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface

Brainlab AG

BodyTom 64

Neurologica Corporation

FAQ 101

Foreo, Inc.

MT-Bone

Mectron S.P.A.

DR 800 with DSA, DR 800

Agfa N.V.

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detectio

Guangzhou Decheng Biotechnology Co., Ltd.

LigaPASS™ 2.0 Ligament Augmentation System

Medicrea International SA

Copra Smile, Copra Supreme Hyperion

Whitepeaks Dental Solutions GmbH

Meriglu Topical Skin Adhesive

M/s. Meril Endo Surgery Private Limited.

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

Medtronic, Inc.

PhySoftAMS®

Physician Software Systems, LLC

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