BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    K2M Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    Brasseler

    FDA UDI
    Provision·B504OMKM715560·

    NON-BR2000 LARGE BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919095415·KM71-556

    Reduction Forceps

    FDA UDI
    I.T.S. GmbH·09120047303870·Reduction Forceps, 400mm, 2x1

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012

    SOMNOSCREEN EEG10-20

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GLIDECROSS SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BONE HOLDING FORCEPS SELF-CENTER SPEED-L

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTD·June 15, 2013

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 21, 2011

    NONE

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code GEI·September 17, 2008

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code FCG·December 26, 2017

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

    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