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

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    BIPAP A 30 VENTILATORY SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30, SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30

    FDA Adverse Event
    Death ·RESPIRONICS, INC.·Product code MNS·September 13, 2023

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776305031·Reno Sharp Point Elevator T-Handle 7"

    Comprehensive® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00880304461093·

    Base Plate Miyabi

    FDA UDI
    Noras MRI products GmbH·04251269204814·

    Comprehensive Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00880304681101·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100530·Caddie, 7.5mm Screws

    MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VERIFY 270FP CHALLENGE PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REALIZE ADJ GASTRIC BAND STR

    FDA Adverse Event
    Injury ·OBTECH MEDICAL SARL_·Product code LTI·June 3, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    COMPREHENSIVE STANDARD TAPER ADAPTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBF·March 17, 2017

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021