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

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    PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH

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

    1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·August 27, 2008

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

    DISTAL FEMUR JTS

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·October 15, 2018

    DISTAL FEMUR JTS / PROXIMAL TIBIA MIG

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 7, 2015

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 26, 2019

    DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014