BEUDAMED
    18 results · 21ms · 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.
    Filters Regulation: Us FDA ×

    SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange

    Orthopedic Instruments

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258695648·

    TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1049092-2018-00287

    FDA Adverse Event
    Injury ·Product code FRO·May 15, 2018

    9618003-2021-01239

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC·Product code MHX·April 30, 2013

    MDT SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC INC.·Product code LWS·August 1, 2008

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·May 11, 2011

    Dressing, wound, drug

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·September 9, 2021

    9618003-2021-01006

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·May 28, 2021

    9618003-2021-01210

    FDA Adverse Event
    Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021

    Dressing, wound, drug

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·October 17, 2022

    9618003-2022-00003

    FDA Adverse Event
    Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·January 6, 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