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
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon
C.R. Bard, Inc.
Europa (Alternative: AiRTouch) portable X-ray system
Livermoretech, Inc.
TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wri
TriMed, Inc.
Alere NT-proBNP for Alinity i Reagent Kit
Axis-Shield Diagnostics, Ltd.
Darwin
Luvo Medical Technologies, Inc.
CoreLink Navigation Instruments
Corelink, LLC
HyperSuture White/Green Extension Line
Threadstone, LLC
RoVo Mechanical Thrombectomy System
Verge Medical, Inc.
PathLoc Lumbar Interbody Fusion Cage System
L&K BIOMED Co., Ltd.
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
Pontemedag
syngo Dynamics (Version VA40E)
Siemens Medical Solutions USA, Inc.
CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestr
Medtronic Sofamor Danek USA, Inc.
Venue Go
GE Medical Systems Ultrasound and Primary Care Diagnostics
AETOS Shoulder System - CONCELOC Glenoids
Smith & Nephew, Inc.
VersaD Delivery Catheter
Unity Medical, Inc.
LINK MobileLink Acetabular Cup System
Waldemar Link GmbH & Co. KG
NAEOTOM Alpha, Scan&GO Software
Siemens Medical Solutions USA, Inc.
Power wheelchair
Zhejiang Zhonglei Medical Technology Co. , Ltd.
Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
Zhejiang Lanhine Medical Products, Ltd.
Flexible Suturing System with Anchors (FSSA)
Integrity Orthopaedics, Inc.
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
Stryker Corporation
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autocla
Strauss Surgical USA
Affinity Fusion Oxygenator System
Medtronic, Inc.
Disposable Stone Extraction Basket
Zhejiang Soudon Medical Technology Co., Ltd.
Vario-Cup System
Waldemar Link GmbH & Co. KG
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2,
Cochlear Americas
Chemfort Female Luer Lock Adaptor
Simplivia Healthcare , Ltd.
Vinyl compound examination gloves
Hebei Titans Hongsen Medical Technology Co., Ltd.
Multi-function Platform Systems (BL-M10)
Shanghai Bele Medical Technology Co.,Ltd
Volumat Polyethylene I.V. Administration Set
Fresenius Kabi
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