BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO TRUPEAK PEAK FLOW METER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0315040·Probe, 1.5 inch Ball, Lenke, Straight, Impaction

    INSTRUMENTS FOR ONE TIME USE - DISPOSABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 11, 2023

    BD ULTRA-FINE¿ II INSULIN SYRINGE 1ML 8MM 30G U-100 100COUNT

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·June 14, 2023

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 2, 2013

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·March 21, 2011

    LINOX SMART S DX 65/15

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·August 19, 2014

    DYNESYS LIS, STABILIZING CORD, 200

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code NQP·May 2, 2019

    BD ULTRA-FINE¿ II INSULIN SYRINGE 1ML 8MM 30G U-100 100COUNT

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·June 13, 2023

    DEPUY CMW 2G 40G

    FDA Adverse Event
    Malfunction ·DEPUY CMW - 9610921·Product code LOD·November 25, 2019

    DEPUY CMW 2G 40G

    FDA Adverse Event
    Malfunction ·DEPUY CMW - 9610921·Product code LOD·November 25, 2019

    DEPUY CMW 2G 40G

    FDA Adverse Event
    Malfunction ·DEPUY CMW - 9610921·Product code LOD·November 25, 2019

    DEPUY CMW 2G 40G

    FDA Adverse Event
    Malfunction ·DEPUY CMW - 9610921·Product code LOD·November 25, 2019

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

    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