BEUDAMED
    1,536 results · 24ms · Sources: EU EUDAMED, US FDA

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    BS-200 CHEMISTRY ANALYZER, MODE BS-200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Cook

    FDA UDI
    COOK INCORPORATED·00827002141414·Fascial Dilator

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695267·Titanium Base Abutment Conical H2mm Engage S

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180503140·Modular LIF Chisel - 18mm

    NDO SURGICAL SURGICAL OVERTUBE

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

    BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910

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

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·April 18, 2018

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·STRYKER NEUROVASCULAR-CALIF·Product code NJE·April 22, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·July 10, 2008

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·February 12, 2018

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 5, 2018

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code NVN·August 12, 2023

    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·August 3, 2018

    NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·June 7, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·September 5, 2018

    ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 18, 2021

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·December 6, 2018

    CONAIR

    FDA Adverse Event
    Injury ·CONAIR CORPORATION·Product code IRT·September 7, 2018