BEUDAMED
    21 results · 30ms · Sources: EU EUDAMED, US FDA

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    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 3, 2020

    SASSY JONES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033454039·

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01307T0·Cervical Rasp, 14 x 11, 7mm, 7 Degree, Tapered

    SASSY JONES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033454053·

    SASSY JONES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033454008·

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01307N0·Cervical Rasp, 14 x 11, 7mm, 0 Degree, No Taper

    SASSY JONES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033454046·

    SASSY JONES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033453995·

    SASSY JONES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033454015·

    SASSY JONES

    FDA UDI
    FGX INTERNATIONAL INC.·00193033454022·

    MITEK CUFFTACK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RUSCH CARLENS EB TUBE WITH CARINA HOOK

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTS·March 15, 2013

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 15, 2014

    Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.

    FDA Enforcement
    Class II ·Terminated·Parks Medical Electronics, Inc·December 5, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014