BEUDAMED
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    KASM KNEE ARTICULATING SPACER MOLDS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131261236·H110, BTE 13 WL 85 SGR HHM

    BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES

    FDA 510(k)
    FDA Class 1 ·Dental

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 29, 2013

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 20, 2011

    ABBOTT VASCULAR AGILTRAC

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LIT·August 20, 2008

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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