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

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    Attune Revision Sleeve LPS Femoral Adaptors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113370·CLEAR CORNEA KNIFE 3.2MM (BX/5)

    STRYKER L3 HYDROLERT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DINAMAP PRO 1000 MONITOR, MODEL 1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONE TOUCH BASIC

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 30, 2002

    ARROW CVC SET: 2-LUMEN 8FR X 20CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·May 7, 2022

    ACCU-CHEK ® PERFORMA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·January 10, 2023

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·March 24, 2022

    ISOFLEX S

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 28, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    UNK_INTRALASE FS1_FEMTOSECOND LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code HNO·May 14, 2024

    CASSETTE MEDI RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LHI·August 29, 2022

    GROSHONG 4F SINGLE-LUMEN PICC (60CM)

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·March 28, 2023

    GORE® CARDIOFORM ASD OCCLUDER

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MLV·January 13, 2023

    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017