BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    neXus Ultrasonic Surgical Aspirator System

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111141577·SKLARLITE-XD OP SCIS SB ST 5"

    Alteon

    FDA UDI
    Exactech, Inc.·10885862513601·ALT NECK TRL EXT SZ11-17

    SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM

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

    ZIRMON SERIES

    FDA 510(k)
    FDA Class 2 ·Dental

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523102198·R CR MAXTM HXL Congruent Tibial Insert Sz A 17mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124435·R CR Tibial Insert Trial Sz A 17mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523172399·CR Tibial Insert Trial with Posterior Pin Relie...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101429·R CR E-MAXTM Vitamin E Congruent Tibial Insert ...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165605·R CR Tibial Insert Trial with Anterior Slot, Sz...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145096·R CR UHMWPE Congruent Tibial Insert Sz A 17mm

    HEDGEHOG

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MNL·August 6, 2024

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 26, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·November 12, 2008

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·July 12, 2013

    IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012