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

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    CORDIA N

    FDA 510(k)
    FDA Class 2 ·Immunology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58208009910·RETRACTOR, ALL TYPES

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209114214·

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·August 18, 1998

    MODIFICATION TO TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·May 8, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 21, 2007

    PROXIMATE RH SKIN STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code GAG·September 27, 2012

    REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET

    FDA Adverse Event
    Malfunction ·SYNTHES SALZBURG·Product code HTD·March 23, 2016

    REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·November 14, 2019

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665

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