BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    OSTEOTOMES OF VARIOUS TYPES

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083011260·Fixed, 10 electrode, MPA, 2mm electrode spacing

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746110795·DB BKT MINI MS LR CUSP 018 T=0 A+3 R=0

    POWERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SOFTSENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMPACTION TOOL

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HWA·June 30, 2014

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·January 3, 2013

    HEARTSTART 4000

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 9, 2010

    OMNIPOD 5 PODS

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·April 11, 2026

    Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; 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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019