BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    PRISMA SEAL

    FDA 510(k)
    FDA Class 2 ·Dental

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002832·VITROS Chemistry Products Calibrator Kit 30

    APPLIED BIOSYSTEMS 7500 FAST DX

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PACIFIER THERMOMETER MODELS VT-901F, VT901C

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2014

    TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·October 19, 2012

    33MM HEMORRHOID STAPLER 3.5MM STAPLES

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·August 10, 2010

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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 GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020