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

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    HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)

    FDA 510(k)
    FDA Class 2 ·Dental

    NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OSTEOPHIL BETA-TCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 29, 2013

    SYNCHRON CX9 ALX

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJC·June 17, 2011

    COYOTE PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·October 1, 2014

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·August 10, 2023

    Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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