BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    ABL90 FLEX, ABL90 FLEX PLUS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197076050·Kirschner abdominal retractor set, oval frame ...

    DC Safety

    FDA UDI
    DC Safety Sales·00816058012243·FAK (DIN)

    STRYKER PEEK TWINLOOP TAC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMC INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PEGASUS YEL 24GA X 0.75IN

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·October 20, 2023

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·November 8, 2017

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEM·Product code MHX·May 23, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 22, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 23, 2017

    OEC UroView 2800, fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 31, 2016

    OEC 9800, fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 31, 2016

    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·September 5, 2012

    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; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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