BEUDAMED
    10 results · 18ms · 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.

    SYNELISA U1-SNRNP (68KDA)-ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515237162·Cook Osteotome, 5mm cut edge, 6 1/4", left guard

    PLIF Allograft

    FDA UDI
    Seaspine Orthopedics Corporation·10889981087692·Offset Curette, Right

    Grasping forceps

    FDA UDI
    SOPRO-COMEG GmbH·04059082022994·

    THERMACOOL TC SYSTEM

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

    FLIXENE IFG VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    15.5F X 24CM DURA-FLOW CATHETER

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code MSD·November 18, 2010

    TI 12-POINT NUT-11MM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·January 25, 2013

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 11, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) 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