BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    VHP 136 TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KSEA MANHES PNEUMOTROCAR

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

    SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RINGLOC RIMCUP SHELL

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code LPH·August 31, 2017

    SPIROFLEX® ANGIOJET® THROMBECTOMY SET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DXE·August 17, 2016

    COVEREDGE 32

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 16, 2022

    MIH MOD CUP INSERTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXH·August 17, 2017

    SI BRITE TIP UNKNOWN

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DYB·April 22, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 27, 2011

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 3, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024