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

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    ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

    SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·January 18, 2017

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DIP·October 1, 2014

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·May 23, 2013

    CAPSURE SP

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

    TURBO-JECT POWER INJECTABLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·July 3, 2018

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·February 3, 2017

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·March 10, 2017

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2017

    1820334-2020-01805

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 5, 2020

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·June 28, 2018

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015