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

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    INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ

    FDA 510(k)
    FDA Class 2 ·Radiology

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694091336·2.4mm x 12mm Fully Threaded Screw

    RE-USEABLE MICROSTAAR INJECTOR, MSI-S

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR

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

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010

    MRHK TIB INS 13MM M/L M2/L2

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·January 28, 2026

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·April 11, 2013

    VITROS 5, 1 FS CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·May 20, 2008

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code HCG·April 13, 2011

    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016