BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    SOFT-COVER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYNTHES (USA) RESORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DESARA SL

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

    TRANSSEPTAL NEEDLE, BRK SERIES

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DRC·June 30, 2023

    SURGIPRO LL

    FDA Adverse Event
    Injury ·DAVIS & GECK CARIBE LTD·Product code GAW·April 22, 2021

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012

    LC4200 PCA AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·October 20, 2010

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·June 2, 2010

    INRATION PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO INC·Product code GJS·May 28, 2014

    STRETCHER CHAIR

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 7, 2010

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·January 15, 2013

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·August 2, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022