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

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    DIAZYME CYSTATIN C POC TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Bone cutters

    FDA UDI
    DFS - DIAMON GmbH·04057176148193·Bone Cutter type 166 CA

    HIP BA BIO 28MM 12/14 + 5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code LZO·September 4, 2019

    POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMAGER II ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FIBULA COMP LOCK PLATE 10H STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·August 24, 2016

    CORONOID PLATE RT STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·June 9, 2016

    PLUM A+ DRIVER ED 2

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2013

    OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·June 2, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 12, 2008

    S3 SHOULDER PLATE 4 HOLE RIGHT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013

    LUMINOS AGILE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHINEERS AG·Product code JAA·November 6, 2024

    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·June 6, 2018

    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.

    FDA Recall
    Terminated ·Ad-Tech Medical Instrument Corporation·Product code LXH·December 20, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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