BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    Comprehensive® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00880304460812·

    8950 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136020679·8950 PED LG MASK W/1410A 2W

    PP positioning unit medial for GE

    FDA UDI
    Noras MRI products GmbH·04251269202414·

    Comprehensive Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00880304681057·

    Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·July 16, 2007

    Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036(refurbished)

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·December 27, 2006

    SALUTE FIXATION DEVICE

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC.·Product code GDW·March 17, 2005

    ALLOFUSE PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOMOS MOTORIZED CRANE II

    FDA 510(k)
    FDA Class 2 ·Radiology

    SALUTE FIXATION DEVICE

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code GDW·June 7, 2006

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·May 15, 2013

    LEAD MODEL 303

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 24, 2014

    STERILE DISP LAP CORD

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·May 25, 2011

    HNM LATERAL ANCHOR

    FDA Adverse Event
    Injury ·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021