BEUDAMED
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    Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein

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

    ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD

    FDA 510(k)
    FDA Class 2 ·Hematology

    ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

    VITROS IMMUNODIAGNOSTICS PRODUCTS, ANTI-HAV IGM REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LOL·August 11, 2011

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 2, 2013

    UNKNOWN LIGASURE INSTRUMENT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GEI·March 23, 2026

    UNKNOWN LIGASURE INSTRUMENT

    FDA Adverse Event
    Death ·COVIDIEN·Product code GEI·March 24, 2026

    UNKNOWN LIGASURE INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GEI·March 23, 2026

    LINER: MPACT FLAT PE HC LINER Ø36/E

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 20, 2023

    STEM: QUADRA-P COLLARED STD STEM SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 31, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 3, 2025

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 25, 2026

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025

    AMISTEM-P COLLARED STD STEM SIZE 6

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 23, 2025

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021