BEUDAMED
    18 results · 35ms · Sources: EU EUDAMED, US FDA

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    ACCESS THYROID UPTAKE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540560032·TRAY

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300101·Mand. 1. Molar band W-Fit right 10

    CHIMAERA Hip Fracture System

    FDA UDI
    ORTHOFIX SRL·18054242514855·CHIMAERA HFS END CAP L10MM STERILE

    Sapphire ULTRA Coronary Dilatation Catheter

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955979316·

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300100101·Mand. 1. Molar band W-Fit right 10

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300100051·Mand. 1. Molar band W-Fit right 10

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300100501·Mand. 1. Molar band W-Fit right 10

    PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ATAC PAK MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PFC* FLUT TIB ROD TRL 115 X 14

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·January 25, 2013

    IN TOUCH EU

    FDA Adverse Event
    STRYKER MEDICAL QUEBEC, LP·Product code FNL·November 19, 2010

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 11, 2014

    2.8MM DRILL BIT/QC/165MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·July 9, 2019

    2.8MM DRILL BIT/QC/165MM

    FDA Adverse Event
    Injury ·Product code HTW·August 6, 2021

    PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex porous coated femoral components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral components may only be used uncemented. All other femoral and tibial baseplate components are indicated for cemented use only. " CR-Flex Mobile articular surfaces are intended for use with a functional posterior cruciate ligament (PCL). UC-Flex Mobile articular surfaces are intended for use with an absent or deficient PCL. " Specific uses with CR-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with CR-Flex Mobile or UC-Flex Mobile articular surfaces, is intended for use when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019