BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    Orion

    FDA 510(k)
    FDA Unclassified ·Unknown

    METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055285·METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE BLA...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006873·Reconstruction Plate Bending Plier, w/Ratchet

    JULIAN THORACIC ARTERY FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896061040·JULIAN THORACIC ARTERY FORCEPS CURVED TIP

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102651·MONOPOLAR RF-CABLE WITH FEMALE BANANA (3 MM DIA...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776411640·DEBAKEY-DEITHRICH VASC TISSUE FCP; OL 9"; TIP 1...

    LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD FILTER NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·November 13, 2019

    THERA-I DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE LTD·Product code FRN·October 20, 2008

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code FSA·July 1, 2013

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·February 2, 2009

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·June 17, 2020

    BD NOKOR¿ FILTER NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·September 19, 2019

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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