BEUDAMED
    10 results · 31ms · Sources: EU EUDAMED, US FDA

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    BIOMET ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Oticon

    FDA UDI
    Oticon A/S·05707131258250·H16, RITE 312 WL SIL

    HALSEY NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896022164·HALSEY NEEDLE HOLDER TUNGSTEN CARBIDE DUST TIP

    CALYPSO SYSTEM WITH DYNAMIC EDGE GATING

    FDA 510(k)
    FDA Class 2 ·Radiology

    CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GENISTRONG

    FDA Adverse Event
    Malfunction ·GENICON·Product code GCJ·October 15, 2017

    1.5X4MM HT SD X-DR SCR, EA

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·May 29, 2013

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·June 13, 2011

    MINIMAL ACCESS ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 1, 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