BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Solax Powered Wheelchair (Models: S7101, S7103)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517576057·CoRoent Ant TLIF Ti, 8x12x40mm 0°

    NitriDerm® EP

    FDA UDI
    INNOVATIVE HEALTHCARE CORPORATION·10813172020885·Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powd...

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704513240·

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100950·DESMARRES LID RETRACTOR #0

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702461213·ELVAREX 3/THIGH HIGH/SLANT, CLOSED TOE, E-VERSI...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702454208·ELVAREX 2/THIGH HIGH/CLOSED TOE, E-VERSION, KNE...

    DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

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

    SYPHILIS HEALTH CHECK

    FDA 510(k)
    FDA Class 2 ·Microbiology

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·February 21, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·April 14, 2015

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 9, 2020

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·December 21, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORP·Product code LZG·June 11, 2013

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 11, 2011

    ACRYSOF TORIC

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code MJP·September 12, 2008

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025