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

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    POLY-MED DISPOSABLE PERSONAL PROTECTION KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591011024·Neoprene Hinged Knee Wrap, Large

    GALAXY FIXATION SYSTEM

    FDA UDI
    ORTHOFIX SRL·18053504366218·Spare part, not medical device, not for sale. R...

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300261·Mand. 1. Molar band W-Fit right 26

    Signa Electrode Gel, 8 oz

    FDA UDI
    VASOMEDICAL, INC.·00817980020856·Signa Electrode Gel, 8 oz

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300260501·Mand. 1. Molar band W-Fit right 26

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300260051·Mand. 1. Molar band W-Fit right 26

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89300260101·Mand. 1. Molar band W-Fit right 26

    Signa Electrode Gel, 2 oz

    FDA UDI
    VASOMEDICAL, INC.·00817980020863·Signa Electrode Gel, 2 oz

    REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SQUALE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2013

    TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·November 19, 2010

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2014

    MULTISCREW CLAMP

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code KTT·July 22, 2015

    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