BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Upper Arm Electronic Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112571·BARRON CORNEAL PUNCH 6.5MM

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113295·STAB KNIFE 30 DEGREE (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113325·PHACO KNIFE 2.8MM ANGLED (BX/5)

    HRH-127-8 HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCESS ALERT GAUGE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

    MAX GR 1X60 T60 01

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GAM·August 3, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    HABIB ENDOHPB

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·August 22, 2024

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code PCU·February 13, 2023

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code PCU·February 13, 2023

    PUMP MMT-1780X 670G MILLIGRAM

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 26, 2026

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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