BEUDAMED
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    GENZYME DIRECT-AMYLASE TEST REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040012628·Zirlux 16+ A4 95X25

    PROGRESS

    FDA UDI
    ABBOTT VASCULAR INC.·08717648137990·HI-TORQUE PROGRESS 200T Guide Wire .014 Straigh...

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR50118431·Quick collar style opening instrument double sided

    OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

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

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 8, 2009

    UNKNOWN COPELAND SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·April 14, 2017

    COPELAND SH HUM SZ4 STND PLUS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·June 8, 2016

    UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·October 21, 2016

    UNKNOWN COPELAND RESURFACING SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·May 16, 2017

    UNKNOWN COPELAND SHOULDER GLENOID COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·July 5, 2017

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code LZG·March 19, 2013

    MAVERICK2 BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 9, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·March 11, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012