BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EVICEL APPLICATION DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 20, 2025

    REPLICON

    FDA Adverse Event
    Injury ·MEDICAL ENGINEERING CORP.·Product code FTR·August 9, 1995

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A,·Product code GFA·April 17, 2013

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·March 25, 2011

    ENDOPOUCH RETRIEVER SPEC BAG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 2, 2008

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 8, 2023

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 8, 2023

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 8, 2023

    3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM

    FDA Adverse Event
    Injury ·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018

    LOCKSCR SYNAPSE TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018

    LOCKSCR SYNAPSE TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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