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

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    GEM-STIM TENS, MODELS GM3XY AND GM3AXY

    FDA 510(k)
    FDA Class 2 ·Neurology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032720·Baltic Denture System BDLoad Sw6 PLSEbm6DFs BL3...

    Ophthalmic Hook

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103333·AKER LENS PUSHER STRAIGHT

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180501177·SHARP COBB, UP-ANGLED 12MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180501221·SHARP COBB, UP-ANGLED 22MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180501191·SHARP COBB, UP-ANGLED 18MM

    TULSA CONTRA ANGLES

    FDA 510(k)
    FDA Class 1 ·Dental

    FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EAGLE VISION

    FDA Adverse Event
    EAGLE VISION·Product code LZU·April 1, 2013

    PT2 GUIDE WIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·March 29, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014

    Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

    FDA Enforcement
    Class I ·Terminated·Quidel Corporation·July 7, 2021

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    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