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

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    Calibrate LTX Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASO Speed Lacer Ankle Stabilizer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357236114·

    LCP

    FDA UDI
    Synthes GmbH·10886982158017·3.5MM LCP PLATE 11 HOLES 150MM

    Fenom Pro

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    E-CUBE 7

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSURE SP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2011

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 5, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021