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

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    HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS

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

    PRESSURE TRAK, MODEL 222-B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOBLAST

    FDA Adverse Event
    Injury ·INTEGRA LIFE SCIENCES·Product code MBP·September 27, 2013

    SIEMENS : ARTISTE MV

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·July 30, 2010

    EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    BD¿ SYRINGE WITH BD LUER-LOK¿ TIP WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·September 19, 2018

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 13, 2013

    QUICKSITE LV

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Recall
    Terminated ·Xeridiem Mediem Medical Devices Inc·Product code PIF·December 23, 2015