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

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    MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)

    FDA 510(k)
    FDA Class 2 ·Hematology

    GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450188644·

    HA PMI FLANGED ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 10, 2020

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 24, 2013

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·September 30, 2014

    MAXIMO II CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC S.A.·Product code NIK·June 16, 2011

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020

    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·December 10, 2013

    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