BEUDAMED
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    BYRD DILATOR SHEATH SET - TEFLON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113516·MINIATURE BLADE #69 (BX/5)

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221112385·3M™ Victory Series™ First Molar Bands, 902-469,...

    IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)

    FDA 510(k)
    FDA Class 1 ·Dental

    O-SCAN MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017

    PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 13, 2017

    BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 18, 2016

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·June 30, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·January 8, 2013

    DUROM US ACETABAR COMPONENT 52/46 L

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·November 10, 2010

    BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024

    BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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