BEUDAMED
    22 results · 25ms · Sources: EU EUDAMED, US FDA

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    ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814534·GENUMEDI SAND SIZE II

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964074431·The ENDO CARRY-ON Procedure Kit contains all of...

    ACCU-CHEK ® GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·February 23, 2022

    ACCU-CHEK ® GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·February 23, 2022

    FRSENIUS PD IQCARD CYCLER

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

    RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 9, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 19, 2014

    FMP HIP

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code LXH·May 3, 2011

    MOTOBAND CP IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·CROSSROADS EXTREMITY SYSTEMS·Product code HRS·March 22, 2019

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021