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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