BEUDAMED
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    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114186·KRATZ POLISHER 21GA SIDE (PK/10)

    Radius T wearable thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814787·GENUMEDI EXTRA WIDE SILVER SIZE V

    Responsive Respiratory

    FDA UDI
    RESPONSIVE RESPIRATORY, INC.·00851440007735·Adult Nebulizer w/ Mask

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113905·VISCO INJECTION CANNULA 25GA

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113868·ROBINS ANTERIOR CHAMBER CANNULA, 30GA

    CRESENT CATHETER CANNULA 32 FR

    FDA Adverse Event
    Malfunction ·MC3, INC.·Product code PZS·November 4, 2024

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 11, 2022

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 8, 2020

    CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 17, 2008

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

    PCA ACE/LOW PROFILE SHELL 52MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·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