BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SYMBIA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131634·TiBase BIO NP .8G E

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694053181·2.0mm Angled Locking L Plate, 6x3 Hole, Left

    OMNIPRO I'MRT

    FDA 510(k)
    FDA Class 2 ·Radiology

    XENON(TM) PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2016

    CURLIN INFUSION IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MED DEVICES GROUP·Product code FRN·May 6, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 1, 2014

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    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