BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    BioFire COVID-19 Test 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517288103·CoRoent® XL-CTW, 14x22x60mm, 10°

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517300539·CoRoent® XLK, 14x18x60mm 10°

    Vu aPod™ - L

    FDA UDI
    Seaspine Orthopedics Corporation·10889981046569·LATERAL TRIAL, WIDE, STANDARD, 14mm X 23mm X 60mm

    OCO DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    Closed System Transfer Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAPTURE-R READY-ID

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·September 18, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 3, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 17, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 2, 2013

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·October 20, 2015

    XP-XP Tibial Tray - Interlok 79 mm Item # 195758

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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