BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOCRATES ROBOTIC TELEMONITORING SYSTEM

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

    XPLAN 2.2 WITH THE BODY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    FDA Adverse Event
    Injury ·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    FDA Adverse Event
    Injury ·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·October 21, 2020

    KLS MARTIN

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 17, 2020

    NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·February 19, 2024

    VASOVIEW HEMOPRO 2 WITH VASOSHIELD

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·April 12, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 20, 2011

    TERUMO CENTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·June 20, 2008

    ERBE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·October 23, 2024

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·September 20, 2024

    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·April 13, 2016

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018