BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MAXCUT CARBIDE BUR (100/pk) FG 332

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811119381·MAXCUT CARBIDE BUR (100/pk) Shape: Pear; Size: ...

    SYRINGE 0.5ML 31GA 6MM 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·February 23, 2021

    THE PICC WAND (R) PEELABLE SAFETY INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OIL FOR EMBRYO CULTURE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·April 29, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 2, 2011

    CAREASSIST

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·August 11, 2008

    NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021