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

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    STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131261281·H11, BTE 13 WL 85 CBE

    CANDELA VBEAM PULSE DYE LASER SYSTEM

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

    COLGATE DESENSITIZING DENTAL CREAM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    REMB MICRO DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 29, 2013

    EON 16-CHANNEL RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 15, 2011

    LARGE OPEN POLY SCREW 4.5 MM X 25 MM

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE·Product code KWP·August 22, 2008

    1.5MM TI CORTEX SCREW SELF-TAPPING 7MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HWC·June 22, 2017

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015