BEUDAMED
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    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114230·LASIK CANNULA FORMS 27GA 4-PORTS

    CellChek 20 rc

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777617·LUMBAMED BASIC DORSAL STAY WM SILVER IV

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10

    NOBELACTIVE TIULTRA NP 3.5X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·May 31, 2021

    NOBELACTIVE TIULTRA NP 3.5X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·May 31, 2021

    MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MIRAGE FULL FACE MASK SERIES 2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 18, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

    STERRAD NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·October 17, 2008

    DA+ T SERIES SR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NVZ·August 11, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 2, 2013

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021