BEUDAMED
    21 results · 35ms · Sources: EU EUDAMED, US FDA

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    HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ArgenZ HT+ 98x30 B3

    FDA UDI
    ARGEN CORPORATION, THE·D818122118·Dental porcelain/ceramic restoration kit

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113478·PS-C Insert, Size 1 x 18mm

    IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SNORE GUARD ADVANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·September 22, 2003

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022

    U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023

    TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IOLMASTER 500

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015

    AJUST ADJUSTABLE SINGLE INCISION SLING

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·May 17, 2013

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 18, 2014

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD.·Product code KWA·June 3, 2011

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·November 19, 2004

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC.·Product code NBW·November 28, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·November 26, 2025

    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

    FDA Enforcement
    Class II ·Ongoing·Lacrimedics Inc·March 9, 2022

    Azurion 5 M12; System Code: (1)722227, (2)722231;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015