BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    O2Vent Optima

    FDA 510(k)
    FDA Class 2 ·Dental

    CETRA

    FDA UDI
    Orthofix US LLC·18257200120406·2-LEVEL PLATE ASSEMBLY, 36MM

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197193191·Tebbet Breast Retractor 190x36...

    DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

    FDA 510(k)
    FDA Class 2 ·Immunology

    STAIR SYSTEMS PACS & DICOM VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 10, 2023

    PROWLER SELECT PLUS 150/5CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRA·April 21, 2023

    TPRLOC COCR CMTD STM T1 12.5MM

    FDA Adverse Event
    Death ·BIOMET UK LTD.·Product code JDI·March 23, 2026

    CMK MOD 12/14 SZ202 L130

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LZO·November 24, 2025

    PINN SECTOR HA ACET CUP 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code LPH·October 21, 2014

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 10, 2013

    STARCLOSE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MGB·August 1, 2011

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWY·July 20, 2023

    ENTERPRISE2 4MMX23MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·March 22, 2023

    ENTERPRISE2 4MMX23MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·October 11, 2023

    CMK MOD 12/14 SZ202 L130

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·January 8, 2026

    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    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