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

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    PRECICE System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

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

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    STRATAFIX UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·August 24, 2017

    VICRYL SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·August 24, 2017

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 17, 2013

    UNKNOWN NEXGEN CR-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 20, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 19, 2008

    INFINION CX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 29, 2022

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·January 4, 2022

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021