BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH

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

    EYE DRAPE

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

    7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HU-FRIEDY PERMA SHARP SUTURES

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAR·May 26, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

    UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code GAD·December 16, 2010

    BELT CLIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 12, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) 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

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024