BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    ARTHROSCOPIC ELECTROSURGICAL PROBE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746110634·DB BKT MINI MS UR CUSP 018 T-2 A+7 R4M

    18M - Loggers - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756018999·ELASTIC SHOULDER IMMOBILIZER

    7.3mm BONE-LOK Implant

    FDA UDI
    INTERVENTIONAL SPINE, INC·81195401087486·7.3mm Diameter by 110-120mm Length

    RTVUE MODEL RTVUE 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    COR12+

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHRON® ALT REAGENT, 2 X 200 TEST

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CKA·July 26, 2011

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 30, 2014

    HEART START XL

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

    6.5CM ADLT CRANI, THIN FT PLATE

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

    SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE

    FDA Adverse Event
    Malfunction ·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015

    COCR FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 6, 2025

    BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 21, 2023

    Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016

    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

    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·August 23, 2017

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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