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

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    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGHT CURE RETAINER

    FDA 510(k)
    FDA Class 2 ·Dental

    TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6

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

    FISHER & PAYKEL HEALTHCARE

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

    PROLIFT +M PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·May 29, 2013

    ATTAIN OTW

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

    DEXTRUS 4135

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

    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