BEUDAMED
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    Agape Cooling Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO

    FDA 510(k)
    FDA Class 2 ·Dental

    CALIBRATING MATERIAL, CAL-PAK, BUFFERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MYOCARDIAL SUTURELESS LEAD

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS·Product code LWS·August 5, 1998

    MYOCARDIAL SUTURELESS LEAD

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS·Product code LWS·August 5, 1998

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·July 1, 2011

    CARE ASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·September 18, 2014

    M2A-TAPER LINER SZ 41/32

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDL·July 2, 2013

    ARCHITECT HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code KSJ·September 1, 2015

    ARCHITECT HBSAG QUALITATIVE II

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code KSJ·December 15, 2017

    ARCHITECT HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·December 30, 2025

    ARCHITECT HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·June 23, 2025

    ARCHITECT HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·February 23, 2026

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016