BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Neurology

    STRAUMANN MEMBRAGEL

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO HERMES O.R. CONTROL CENTER

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

    2.0MM KIRSCHNER WIRE W/ DRILL TIP/100MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·May 29, 2013

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 16, 2011

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·August 21, 2008

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 2, 2026

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    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