RecallHawk

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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