BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Hematology

    PE anti-human CD13

    FDA UDI
    BIOLEGEND, INC.·00810034701091·URL: https://www.biolegend.com/en-us/products/p...

    STORZ DISPOSABLE BIPOLAR PENCILS

    FDA 510(k)
    FDA Class 2 ·Neurology

    MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FLEX ARM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·September 26, 2017

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP.·Product code MVK·June 13, 2014

    SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 8DEG-STER

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code MQP·February 28, 2013

    INTEGRATED APD SET W/CASSETTE3 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 9, 2011

    FLEX ARM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·September 26, 2017

    Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 2, 2018