BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SURGISEAL TOPICAL SKIN ADHESIVE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ArgenZ HT+ 98x14 ML OM2B

    FDA UDI
    ARGEN CORPORATION, THE·D818130329·Dental porcelain/ceramic restoration kit

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1303290·

    FASTPACK FREE T4 IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACRYSOF

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH LTD/HUNTINGTON·Product code HQL·May 22, 2013

    CRYSTALLINE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 16, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 22, 2008

    NSK Z85L

    FDA Adverse Event
    Malfunction ·NAKANISHI, INC. 9NSK)·Product code EGS·March 24, 2015

    NSK Z95L

    FDA Adverse Event
    Malfunction ·NAKANISHI, INC. (NSK)·Product code EGS·April 8, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022