BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    PREP SHAVE KIT (NON-STERILE)

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

    SIRORETRO

    FDA UDI
    SIRONA Dental Systems GmbH·E27659250160·SIRORETRO KL PROD

    DePuy Songer Spinal Cable System

    FDA UDI
    Pioneer Surgical Technology, Inc.·10846468005235·Bar, Round, Ti 2-Pack, NS, AcroMed

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837015152·

    Duo Lumbar Interbody Fusion Device

    FDA UDI
    SPINEOLOGY INC.·M7402925016·Duo, Hyper-Lordotic, 50 x 16mm

    Songer® Spinal Cable System

    FDA UDI
    Pioneer Surgical Technology, Inc.·00840298704446·(2) Bar, Round

    IMPROVED DENTAL CHAIR

    FDA 510(k)
    FDA Class 1 ·Dental

    PEDIATRIC AND INFANT CATH KITS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COULTER® ACT DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC·Product code GKZ·December 7, 2010

    SHARPS CONTAINER

    FDA Adverse Event
    Malfunction ·POST MEDICAL, INC.·Product code FMI·March 12, 2024

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 18, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 22, 2013

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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