BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10

    ConMed

    FDA UDI
    Provision·B504OM50231840·

    NA

    FDA UDI
    STERILMED, INC.·10888551019880·SAW BLADE SAGITTAL MICRO ACL TAPRED/FINE TOOTH

    CONMED

    FDA UDI
    Conmed Corporation·10845854000458·ACL BLADE, FINE, 9.5 X 41 X 0.4 MM

    RS BIOTECH GALAXY 'R' CO2 INCUBATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HOMMED CENTRAL STATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEE H10

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011

    ACL TOP

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005

    ACL TOP

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005

    ACL ADVANCE

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·February 27, 2013

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·March 16, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    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