BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    XGEO GU60

    FDA 510(k)
    FDA Class 2 ·Radiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756612586·Wrist Splint

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780165132·Integra® Jarit® Baumgartner Needle Holder, 5-1/...

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138003446·DELUXE ABDOMINAL BINDER 9IN XXLARGE

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619043674·TD Torque-Line Catheter, 7F, 4 lumen, 110 cm

    ATAC CALCIUM REAGENT AND ATAC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ORTHODONTIC SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    TD TORQUE LINE CATHETER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DYG·October 4, 2016

    AMISTEM C FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·March 7, 2013

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·January 10, 2007

    THERMODILUTION CATHETER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DYG·July 2, 2007

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 21, 2013

    DUROM US ACETABULAR COMPONENT 50/44 J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 6, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 5, 20.0 mm; Ref 96-0554.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018