BEUDAMED
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    ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)

    FDA 510(k)
    FDA Unclassified ·Unknown

    SYSTEM 98XT, ENGLISH, 110V

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

    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

    CORE SUMEX DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 6, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·April 29, 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

    EDWARDS TRANSCATHETER INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 11, 2019

    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