BEUDAMED
    26 results · 23ms · Sources: EU EUDAMED, US FDA

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    VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743564·LEVAMED ANKLE SUPPORT SILVER V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743687·ACHIMED ACHILLES SUPP SILVER V

    n/a

    FDA UDI
    Ortho Development Corporation·00822409073863·10/12 Resection Guide 90degx15mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199694·Modular Knee Stem Pilot 21mm x 150mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102150·Shaver, Open 15mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023987·PADDLE SPREADER, 15MM

    BIORAPID MONONUCLEOSIS

    FDA 510(k)
    FDA Class 2 ·Immunology

    SWIVEL ELBOW

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862158215·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

    RAINBOW DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·April 18, 2017

    RADICAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·April 16, 2015

    HIRES 90K IMPLANT

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·April 3, 2013

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    FDA Adverse Event
    Injury ·COSTA RICA·Product code LTI·May 7, 2008

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·April 5, 2011

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 5, 2025

    LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 1, 2023

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013