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

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    LP-60 LOW PRESSURE INFLATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909102052·REVELATION DIAMOND 830-010C - 5 PACK

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756350006·ENT MINOR PACK

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756019170·WRIST AND FOREARM

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331120572·endoscopic clip applier, not rotatable, for lar...

    H.A.M., 05-Channel w/ blank insert holes

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024558·

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112267·SURG-I-BAND ORANGE

    H.A.M.,05-Chan w blank insert holes,Slot

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024565·

    Reicodent

    FDA UDI
    devemed GmbH·04061644050376·BASIC CLIP Wash Tray (271,5x177,5x33,0mm) empty

    Grasping forceps

    FDA UDI
    SOPRO-COMEG GmbH·04059082022161·

    AAIO-7, AAIO WIRLESS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 5, 2021

    CADD ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL MD, INC·Product code FPA·July 22, 2024

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #SIZE 5/11 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 20, 2023

    3 GANG 1O2¿ MANIFOLD W/CHECK VALVE, ROTATING LUER, APPX 1.2ML

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·October 6, 2023

    33MM HEMORRHOID STAPLER 4.8MM STAPLES

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·November 22, 2010

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    EMG TECHNOLOGY CO. LTD·Product code BTI·July 2, 2014

    PARKER BATH

    FDA Adverse Event
    Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code ILJ·November 23, 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