BEUDAMED
    374 results · 61ms · Sources: EU EUDAMED, US FDA

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    Restore IQ System

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001443·Platform, Medium - Purple

    Restore IQ System

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001481·Platform, Large - Blue

    Restore IQ System

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001467·Platform, Small - Blue

    Restore IQ System

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001450·Platform, Large - Purple

    Restore iProtect Module

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001498·Instrument Module, 10 x 5 inch size

    Restore IQ System

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001436·Platform, Small - Purple

    Restore Advanced Stringer System

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001429·Expandable Stringer, 9 inch size for Restore iQ...

    Restore Intelligent Sterilization Tray

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001405·modular tray, large size - 10 x 20 inch

    Restore IQ System

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001474·Platform, Medium - Blue

    Restore Advanced Stringer System

    FDA UDI
    RESTORE MEDICAL SOLUTIONS, INC.·00860190001412·Expandable Stringer, 10 inch size for Restore I...

    RESTORE MEDICAL

    FDA Adverse Event
    Malfunction ·RESTORE MEDICAL, INC·Product code LRK·May 3, 2006

    SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

    FDA Enforcement
    Class II ·Terminated·ASI Medical, Inc.·December 25, 2013

    SYMPHONY

    FDA Adverse Event
    Other ·ELA MEDICAL S.A.S.·Product code DXY·February 24, 2006

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·May 12, 2023

    Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: ¿ Kinetra¿ Model 7428 or Soletra¿ Model 7426 Neurostimulator ¿ Activa¿ PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ¿ Soletra Model 7426 Neurostimulator ¿ Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·December 26, 2012

    VIVERA RETAINER

    FDA Adverse Event
    Injury ·ALIGN TECHNOLOGY, INC.·Product code DYT·October 18, 2022

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 26, 2026

    CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC STYLET

    FDA Adverse Event
    Death ·AVANOS MEDICAL INC.·Product code KNT·May 9, 2023

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code PPN·July 11, 2024

    SPIRIT SELECT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS·Product code FNL·June 30, 2015