BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    TOX A/B TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292909·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049248·K-Wires, Single trocar, .045-inch (1.1mm) diame...

    K-Wire w. trocar/round end 1.14mm/152mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM711820·K-Wire w. trocar/round end 1.14mm...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659484450·K-Wire w. trocar/round end _x000D_...

    ri-former Predictive Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013

    FDA 510(k)
    FDA Class 2 ·Dental

    AGC DA2000 KN TIB BRG 71/75X14

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·August 31, 2016

    BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HRY·June 16, 2017

    AGC V2 INTERLOK TIB 10X 71MM

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code HRX·May 19, 2017

    PRECISION QID

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 1, 2013

    MULTI BITE BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·January 26, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    AQUATEC OPERATIONS GMBH·Product code ILS·July 31, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017

    AGC V2 INTERLOK TIB 8 X 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·April 12, 2017

    AGC V2 INTERLOK TIB 8 X 79MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 22, 2016

    AGC REVISION KNEE TIBIAL AUGMENTATION

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·June 28, 2017

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017