BEUDAMED
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    WRIGHT MEDICAL TECHNOLOGY SAWBLADES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221118240·3M™ Victory Series™ Second Molar Bands, 955-229...

    PACING/PSI KIT: 5 FR/6 FR 2-L

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015

    LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GELWEAVE STRAIGHT GRAFT

    FDA Adverse Event
    Injury ·VASCUTEK LTD·Product code DSY·August 10, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·February 11, 2013

    CURRENT PLUS DR, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·July 24, 2014

    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 31, 2016

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013