BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    SET-5002

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BBL™ Coagulase Plasma, Rabbit with EDTA

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902408278·BD BBL™ Coagulase Plasma, Rabbit with EDTA

    SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set

    FDA 510(k)
    FDA Class 2 ·Hematology

    PANALOK LOOP ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL COAGULASE PLASMA, RABBIT WITH EDTA

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code JTL·July 29, 2021

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 7, 2024

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 10, 2014

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011

    NCB CANNULATED SCREW, 4.0MM DIAMETER, 28MM

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code HWC·July 18, 2013

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020