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

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    ENDOSSEOUS DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

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

    MODIFICATION TO CLASSIC GREAT TOE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVIATOR ASSY TWO LEVEL PLATE SIZE 28

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016

    120MM INSUFF NEEDLE

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code FHO·April 16, 2020

    SHELL POROUS WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·May 26, 2017

    MINI-CAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 6, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    FDA Adverse Event
    Death ·SORIN GROUP CANADA INC., MITROFLOW DIV.·Product code LWR·May 11, 2011

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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