BEUDAMED
    11 results · 13ms · Sources: EU EUDAMED, US FDA

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    Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code JQP·March 2, 2005

    Banana Peel™ Sheaths - 14/30 Catalog Number: 260203

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

    Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 15, 2005

    22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.

    FDA Recall
    Terminated ·Spinal Specialties, Inc·Product code CAZ·April 15, 2005

    Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.:4043, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.

    FDA Recall
    Terminated ·Spinal Specialties, Inc·Product code CAZ·April 15, 2005

    VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLI·March 15, 2005

    ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727

    FDA Recall
    Terminated ·Sunrise Medical Inc·Product code ITI·November 15, 2005

    LIFEPAK 12 defibrillator/ monitors biphasic

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code MKJ·January 15, 2005

    Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LOM·December 15, 2005

    S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·October 31, 2005