BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    QUATTRO CATHETER MODEL IC4593

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Eccentric

    FDA UDI
    Cendres+Métaux SA·07640173090007·Eccentric Transfer jig

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699524·Core Tool for Paltop Equator

    Up&Up

    FDA UDI
    TARGET CORPORATION·06945397906181·Heat wraps for neck 4 pack

    SUPERBOND

    FDA 510(k)
    FDA Class 2 ·Dental

    AGILTRAC .018 PERIPHERAL DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW

    FDA Adverse Event
    Injury ·BIOMET·Product code HSB·March 13, 2012

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·March 1, 2012

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·April 15, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 25, 2011

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 3, 2008

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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