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

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    SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEOCIF INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018

    ONTRAK TESTCARD 9

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ENDOCARE PERCUTANEOUS ACCESS SET

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

    NEOCIF INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·May 3, 2013

    TRANSTAR STRETCHER FRAME

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·September 5, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 3, 2011

    OXYSURE

    FDA Adverse Event
    Injury ·OXYSURE·Product code CAW·March 19, 2014

    OXYSURE

    FDA Adverse Event
    Injury ·OXYSURE·Product code DQA·March 19, 2014

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HSB·November 7, 2013

    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