BEUDAMED
    12 results · 25ms · 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 ×

    Smartcord, Smartcord X

    FDA 510(k)
    FDA Unclassified ·Unknown

    BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CADD MEDICATION CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·March 31, 2026

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 17, 2024

    CADD MEDICATION CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V·Product code FPA·April 1, 2026

    CADD MEDICATION CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V·Product code FPA·April 1, 2026

    DISTRACT ADJUSTABLE W/LONG FEET L320 F/P

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

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 21, 2011

    4 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·September 17, 2008

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

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

    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