BEUDAMED
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    DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120240·Screwdriver, Extended Tab, Cannulated, SNI 1, L...

    PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 26, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 30, 2024

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 2, 2024

    640G INSULIN PUMP MMT-1711K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2024

    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

    FDA Enforcement
    Class II ·Ongoing·Entopsis , Inc.·April 5, 2023

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 2, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 2, 2024