BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743656·ACHIMED ACHILLES SUPP SILVER II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743489·LEVAMED ANKLE SUPPORT SILVER II

    SILVERVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948002713·SILVERVENT Jatho 2 IC, SIZE 12

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481475531·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023956·PADDLE SPREADER, 12MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102120·Shaver, Open 12mm

    SCFE Screw

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132114476·4.0mm X 12mm SHORT THREAD CANNULATED SCREW

    KSEA CHARDONNES MORCELLATION KNIFE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRESSUREWIRE CERTUS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL SYSTEMS AB·Product code DQX·March 27, 2013

    6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 7, 2011

    INSTANT RESPONSE ES GENERATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN LP, (VALLEYLAB)·Product code GEI·April 14, 2008

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Enforcement
    Class II ·Terminated·Ondamed Inc·May 16, 2018

    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