BEUDAMED
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    PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOCAL SIM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    I-STAT CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 31, 2023

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 18, 2021

    INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY SMALL LEFT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·November 30, 2023

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO INC·Product code GJS·February 26, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·February 15, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 18, 2021

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022

    ACHIEVE ADVANCE MAPPING CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DRF·July 25, 2023

    ACHIEVE ADVANCE MAPPING CATHETER

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DRF·July 25, 2023

    ACHIEVE MAPPING CATHETER - 20 MM

    FDA Adverse Event
    Death ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·April 15, 2024

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Death ·MEDTRONIC CRYOCATH LP·Product code OAE·April 15, 2024

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·July 25, 2023

    ALINITY I HBSAG QUALITATIVE II REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·January 26, 2026

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 18, 2013

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·July 25, 2023

    BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 22, 2020