BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    GENII ARC SMART ARGON PROBE

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

    CENTRIMAG DRAINAGE CANNULA KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KYPHON HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020

    CARDIOHELP-I

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 13, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 30, 2014

    ADAPTA SR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011

    SHILEY DISPOSABLE INNER CANNULA

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO·Product code BTO·August 20, 2008

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

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