BEUDAMED
    23 results · 28ms · Sources: EU EUDAMED, US FDA

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    SPERM WASH MEDIUM, CAT# 2003/2005

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092133019·NobelActive™/Conical-compatible RP Multi-Unit T...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040004531·Natural Elegance Composite Tip

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092116814·NobelActive™/Conical-compatible RP Multi-Unit T...

    Provena Midline

    FDA UDI
    Bard Access Systems, Inc.·00801741216039·Catheter Placement Kit

    PQ1

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAILS-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·September 20, 2013

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·September 20, 2013

    MAYFIELD HEAD HOLDER

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·October 7, 2016

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·May 18, 2015

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013

    DORSAL SMARTLOCK DR PLATE, WIDE, LEFT

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HRS·February 18, 2011

    ACCU-CHEK D-TRON PLUS

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·February 19, 2008

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 27, 2015

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 11, 2018

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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