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

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    Insightra Freedom Ventral Hernia Repair System

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

    INDISCAL DIGITAL MANOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LOW FLOW OSV II HYDROCEPHALUS VALVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 5, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 3, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·May 26, 2011

    PERF CON TIB BRG LRG 22X60

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    NON-POROUS PERF TIB TRAY-LGE

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    PERF ANAT TIBIAL STEM 120X14X5

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015