BEUDAMED
    78 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    SPY ANALYSIS TOOLKIT, MODEL SA9000

    FDA 510(k)
    FDA Class 2 ·Radiology

    BILAYER MATRIX WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    QUADRA BROACH SIZE 0

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP L

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

    SCORPIO TS DISTAL BLOCK

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 14, 2011

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 18, 2008

    VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 7, 2021

    VERSAFITCUP CC TRIO ACETABULAR SHELL 58

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·April 8, 2013

    COCR BALL HEADS 32 SIZE M.

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 29, 2011

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 19, 2017

    QUADRA H FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·May 15, 2026

    QUADRA R FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 3, 2026

    VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM 48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 10, 2022

    LINER: MPACT HOODED PE HC LINER Ø32/D

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 23, 2019

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021

    QUADRA H FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 2, 2025

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2016

    BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 21, 2022

    CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·August 2, 2021