BEUDAMED
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    HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R

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

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2024

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 14, 2022

    INTERGRATED APD SET

    FDA Adverse Event
    Malfunction ·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049957000028·Compact Sigma Lithotripter, 220V, 60 Hz

    neria™

    FDA UDI
    Unomedical A/S·05705244003590·Single use infusion set for subcutaneous infusi...

    thalaset™

    FDA UDI
    Unomedical A/S·05705244005457·Single use infusion set for subcutaneous infusi...

    thalaset™

    FDA UDI
    Unomedical A/S·05705244001497·Single use infusion set for subcutaneous infusi...

    neria™

    FDA UDI
    Unomedical A/S·05705244000759·Single use infusion set for subcutaneous infusi...

    MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GYNECARE TVT ABBREVO CONTINENCE SYSTEM

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

    GYNECARE TVT-ABBREVO MINI LCM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 30, 2021

    RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·July 23, 2018

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 9, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 19, 2014

    HEMODIALYSIS TWO-LUMEN K IT: 2-L 28 FR

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code MSD·May 4, 2011

    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

    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