BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    ESOPHAGEAL BALLOON DILATOR

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

    OnBrace Crown UL5 w/ AWT (5/pk)

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199014240·

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083010706·Fixed, 4 electrode, CS, 10mm electrode spacing

    OSTA MAXIGRO AND REGIGRO

    FDA 510(k)
    FDA Class 2 ·Dental

    KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·August 19, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·January 3, 2013

    HYDROCOIL 10-SYSTEM COIL

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code HCG·October 29, 2010

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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