BEUDAMED
    13 results · 17ms · Sources: EU EUDAMED, US FDA

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    MYERSON IR DENTURE BASE

    FDA 510(k)
    FDA Class 2 ·Dental

    BASE

    FDA UDI
    Nuvasive, Inc.·00887517701633·BASE Trial, 8x34x24mm 10°

    VENTRALIGHT

    FDA UDI
    Davol Inc.·00801741031687·Ventralight ST Mesh, 8" x 10" (20.3 cm x 25.4 c...

    FC-1000 FLUOROSCOPIC IMAGING COMPUTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PHASIX ST MESH

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·July 7, 2022

    ENDEAVOR RESOLUTE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·February 11, 2013

    FORTIFY DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011

    POWERPICC SOLO 4F SL CATHETER BASIC TRAY

    FDA Adverse Event
    Injury ·BARD ACCESS SYSTEMS·Product code LJS·July 17, 2014

    VENTRALIGHT ST MESH

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 7, 2016

    Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·September 26, 2012

    Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

    FDA Recall
    Terminated ·Davol, Inc., Subs. C. R. Bard, Inc.·Product code FTL·September 4, 2012

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021