BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Baby Tischler Biopsy Punch

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030129·Baby Tischler Biopsy Punch 8 1/2" (216mm) Blue ...

    Asnis

    FDA UDI
    Stryker GmbH·07613154631278·CANNULATED SCREW

    Verteloc Lordotic Lumbar Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215129415·

    EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CSLP EXPANSIONHEAD

    FDA Adverse Event
    Malfunction ·SYNTHES SPINE·Product code KWQ·March 28, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 27, 2011

    IMPLANTIUM

    FDA Adverse Event
    Injury ·DENTIUM·Product code DZE·April 15, 2008

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·August 20, 2012

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013