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

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    ANGIOGRAPHIC SOFT TIP CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGICAL SIMPLEX P WITH TOBRAMYCIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HORIZON REGULAR ETCHING GEL

    FDA 510(k)
    FDA Class 1 ·Dental

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 14, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 1, 2010

    ACCU-CHEK ® INFORM II TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2014

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 17, 2012

    SOFT-VU HALO

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INC.·Product code DQO·November 16, 2007

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQO·September 28, 2012