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

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    FDA 510(k)
    FDA Class 2 ·Dental

    NexxZr™ T / D-100-10-NT-D200-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113542·

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981190583·Interbody, 11mm x 32mm x 14mm, 5 Deg

    WaveForm TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981288884·Interbody, 11mm x 32mm x 14mm, 5 Deg, 3D

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981204730·Trial, 11mm x 32mm x 14mm, 5 Deg

    AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERIFIX CATHETER CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NA

    FDA UDI
    GENDRON, INC.·00842307103073·STRETCHER,BARIATRIC WITH POWDER COAT ...

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·July 31, 2017

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 29, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·October 1, 2014

    2-DAY INFUSION KIT

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS KALAMAZOO·Product code FRN·June 11, 2011

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·September 15, 2015

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017

    BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·August 4, 2022

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 24, 2016