BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    Vivid T8, Vivid T9

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vanguard Select Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304555631·

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362708·Integra® Miltex® Halsted Mosquito Forceps, 4-3/...

    EXTREMITY MEDICAL COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DELTRAN PLUS

    FDA Adverse Event
    Malfunction ·UTAH MEDICAL PRODUCTS, INC.·Product code CBT·February 12, 2020

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Malfunction ·LDR MEDICAL·Product code OVE·February 4, 2020

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code OVE·April 13, 2020

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM

    FDA Adverse Event
    Malfunction ·LDR MEDICAL·Product code OVE·August 6, 2020

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN...·Product code CBK·June 17, 2013

    G2 FILTER SYSTEM, FEMORAL

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 24, 2007

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 22, 2008

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

    SPACER, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code OVE·August 17, 2022

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014