BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    J105 JAMES SURGICAL SYSTEM I/A PACK

    FDA 510(k)
    FDA Class 1 ·Neurology

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707114312·Votion .018 R UR 4/5 HK G/O -7T 0A 2DO (10PK)

    Pinnacle

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730010445·Pinnacle .018 R UR 4/5 HK G/O -7T 0A 2DO (10PK)

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730008619·Votion .018 R UR 4/5 HK G/O -7T 0A 2DO (10PK)

    Pinnacle®

    FDA UDI
    Ortho Organizers, Inc.·00190707112400·Pinnacle .018 R UR 4/5 HK G/O -7T 0A 2DO (10PK)

    Momentum™ Posterior Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IGLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·January 11, 2013

    SYNCHRON® LX20 PRO ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 1, 2010

    HYLAMER 10D 52OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code HRY·July 3, 2014

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024