BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    CAS PSI SHOULDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    S-ROM*SLEEVE PRX ZTT, 18D-LRG

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 16, 2013

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 16, 2013

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 16, 2013

    UNK

    FDA Adverse Event
    Other ·RAYNER INTRAOCULAR LENSES LTD.·Product code HQL·May 22, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    SUMMIT CEMENTED STEM SZ7 STD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 20, 2008

    PINNACLE SECTOR II CUP 56MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 16, 2013

    MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022

    MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022

    NSK X95

    FDA Adverse Event
    Injury ·NAKANISHI, INC.·Product code EGS·May 26, 2015

    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