BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    AVL OMNI ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NA

    FDA UDI
    Richard Wolf GmbH·04055207023037·SEALING CONE Ø 15-20MM for subcutaneous fascia...

    VITEK RAPID CALL-GRAM NEGATIV IDENT CARD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    WET SENSE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CER OPT TYPE 1 TPR SLEVE 0MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·June 13, 2019

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 7, 2013

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·January 4, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014

    G7 OSSEOTI 3 HOLE SHELL 52MM E

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 13, 2019

    ACT ARTIC E1 HIP BRG 28X42MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·June 13, 2019

    G7 DUAL MOBILITY LINER 42MM E

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 13, 2019

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025