BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    Scrambler Therapy Technology (Model ST-5A)

    FDA 510(k)
    FDA Class 2 ·Neurology

    BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHRON CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYNTHES IN-SITU BENDER/CUTTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·February 19, 2016

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·December 22, 2015

    HAMILTON-C6

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 10, 2025

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 16, 2008

    IPUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013

    LIGACLIP*ENDO

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 17, 2018

    EVALUATION BILIARY CONTROLLED-RELEASE STENT ¿ UNCOVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·March 12, 2015

    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