BEUDAMED
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    dpl II Panel

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

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100806·FLIERINGA FIXATION RING 19MM

    FASTPACK TSH IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WHEELCHAIR MODEL STS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNKNOWN SHELL

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·August 14, 2017

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·August 14, 2017

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·August 14, 2017

    LCP DHS-PL 135° 4HO L38/92 SST

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·June 15, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 17, 2008

    M2A TAPER LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·August 17, 2017

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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