BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

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    FLEXIBLE CHOLEDOCHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    D-100

    FDA UDI
    BIO-RAD LABORATORIES, INC.·00847817025679·D-100 HbA1c Elution Buffer A

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746135408·DB BKT MINI MS LOWER ANT 018 T=0 A=0 R=0

    Zavation

    FDA UDI
    Zavation LLC·00842166180741·Driver Sleeve

    PeriBeam® Pericardial Membrane

    FDA UDI
    TAMABIO CO., LTD.·04589795950241·

    Hydrate

    FDA UDI
    BRIVANT LIMITED·00816349011498·

    ASCENT KNEE REVISION FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TROKAMED MORCELLATOR

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

    DIACAM (510(K) K 901019)

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001

    BIVONA CUSTOMER TTS FLEXTEND TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL, INC.·Product code JOH·June 17, 2014

    ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 17, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 8, 2013

    BD ECLIPSE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·August 28, 2019

    VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code NJT·August 2, 2018

    VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901010, 10mm, 5.5mm dia x 110mm, size: 10mm x 110mm, for spinal fixation.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NQP·November 12, 2007

    PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024