BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    BACT/ALERT MP Reagent System

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACT/ALERT MP - 419744

    FDA Adverse Event
    Malfunction ·BIOMERIEUX INC.·Product code MDB·December 5, 2019

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Oticon

    FDA UDI
    Oticon A/S·05707131338792·SIYA 1, BTE 13 2.4G 85 C063

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319741429·Hartman Nasal Cutting Forceps, 5" (12.5cm), 9mm...

    FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIPIDPRO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    M2A 38MM MODULAR HEAD +3MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 16, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 28, 2011

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·April 22, 2019

    BRASSELER/NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·April 19, 2019

    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 REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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