BEUDAMED
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    BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950026487·LATEX TUBING 1/16"X1/32" AMBER 50' RL NS W/L

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032940·Baltic Denture System BDLoad Sm7 PLSEbm6DFs C1 ...

    LP Low Profile

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746162077·DB BKT LP UL CEN 022 T+7 A+5 R=0

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981214210·465 Screw M5 x 0.8

    SHELHIGH BIORING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL SDN BHD·Product code BTR·April 1, 2013

    CONCERTO II CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·March 29, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·April 23, 2008

    EDWARDS INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025

    EDWARDS INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025

    Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005

    EDWARDS INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022

    ACCUVUE ADVANCE

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·October 19, 2007

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024