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

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    MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ROLLO 210x30x19E DELTA 60 - OEM ET MEDI

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763005728·

    MICROPOWER

    FDA UDI
    Conmed Corporation·20845854013189·MICROPOWER MEDIUM SPEED DRILL, PERMANENT LEVER

    2040 Ceramic Brackets

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746005244·COSMETIC 20/40 UR CEN 022 T+12 A+5 R=0

    MICROPOWER

    FDA UDI
    Conmed Corporation·10845854013182·Micropower Medium Speed Drill, Permanent Lever

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120210·Assembly, Screwdriver, Extended Tab, Cannulated...

    LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LASER 20

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 24, 2025

    SP IMPL., 4.8MM WN, SLACTIVE 8MM

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·June 28, 2021

    SP 4.1MM RN, SLACTIVE 10MM, TIZR, NTP

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·October 8, 2021

    CVC SET: 2-LUMEN 4FR X 1 3CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL CINC·Product code DQY·March 20, 2013

    INSYNC MAXIMO

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·March 16, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·March 26, 2008

    13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

    FDA Enforcement
    Class II ·Terminated·Cairn Diagnostics·February 24, 2021

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 12, 2024

    COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·December 2, 2021

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014