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

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    DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH

    FDA 510(k)
    FDA Class 2 ·Immunology

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"

    HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CLIRANS E-SERIES HOLLOW FIBER DIALYZERS

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

    SYSTEM 98XT, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·February 3, 2026

    X3 TRIATHLON CS INSERT #3 9MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014

    LINEAR 3-6

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2024

    SYSTEM 98XT

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·September 22, 2025

    ASSY,ENGLISH,DOMSTC,110V,SYS98

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·December 26, 2025

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·November 3, 2025

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·November 18, 2025

    DUAL COOLER/HEATER

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·April 12, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·June 19, 2008

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 19, 2011

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·January 14, 2026

    ASSY,ENGLISH,DOMSTC,110V,SYS98

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·September 15, 2025

    SENSATION 7FR. 34CC IAB

    FDA Adverse Event
    Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 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

    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