BEUDAMED
    27 results · 48ms · Sources: EU EUDAMED, US FDA

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    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·February 12, 2025

    ARTEFILL

    FDA Adverse Event
    Other ·ARTES MEDICAL, INC.·Product code LMH·March 10, 2009

    ELEVESS

    FDA Adverse Event
    Injury ·ARTES MEDICAL INC·Product code LMH·December 26, 2008

    ARTEFILL

    FDA Adverse Event
    ARTES MEDICAL, INC.·Product code LMH·March 31, 2014

    ARTEFILL

    FDA Adverse Event
    Injury ·ARTES MEDICAL, INC.·Product code LMH·August 15, 2008

    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

    FDA Recall
    Terminated ·Arc Medical Inc·Product code BYD·February 19, 2015

    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

    FDA Enforcement
    Class III ·Terminated·Arc Medical Inc·May 20, 2015

    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

    Medex Instrumenten Service

    Importer
    🇳🇱 Netherlands·8 Manufacturers

    INTRAMED

    Importer
    🇦🇹 Austria·9 Manufacturers

    Surgipa Medical, spol. s r.o.

    Importer
    🇨🇿 Czechia·7 Manufacturers

    SEDA S.p.A.

    Importer
    🇮🇹 Italy·15 Manufacturers

    Neuromed Spa

    Importer
    🇮🇹 Italy·9 Manufacturers

    BOHEMIA MEDICAL s.r.o.

    Importer
    🇨🇿 Czechia·7 Manufacturers

    Promedics Medizinische Systeme GmbH

    Importer
    🇩🇪 Germany·12 Manufacturers

    Medical Technology Promedt Consulting GmbH

    Authorized representative
    🇩🇪 Germany·194 Manufacturers·10009 Devices

    mdi Europa GmbH

    Authorized representative
    🇩🇪 Germany·132 Manufacturers·4741 Devices

    OneMed Oy

    Importer
    🇫🇮 Finland·4 Manufacturers

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    SADENT A.E.B.E.

    Importer
    11 Manufacturers