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

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    DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ANS AXXESS PERCUTANEOUS LEAD

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710620340120·Quad Channel Met-Traverse, 34mm x 12mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710620340130·Quad Channel Met-Traverse, 34mm x 13mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710620340080·Quad Channel Met-Traverse, 34mm x 8mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710620340140·Quad Channel Met-Traverse, 34mm x 14mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710620340070·Quad Channel Met-Traverse, 34mm x 7mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710620340090·Quad Channel Met-Traverse, 34mm x 9mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710620340110·Quad Channel Met-Traverse, 34mm x 11mm

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·April 16, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·March 18, 2011

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    FDA Adverse Event
    Malfunction ·MEDTRONIC VCARDIOVASCULAR GALWAY·Product code NIQ·June 13, 2008

    ENCOREANYWHERE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 17, 2016

    Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022