BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    THEKEN REVEAL VBR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    MedGyn Pessary Cube w/o drain # 3

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050058·Cube Pessary is used treat uterine prolapse.

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306810473·Operating Scissors, Curved, B/B, 16.5cm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710420500580·Anterior Lateral Wedge Osteotomy Guide, 50mm x ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710410500580·Anterior Closing Wedge Osteotomy Guide, 50mm x ...

    PERSONA® Persona SoluTion™

    FDA UDI
    Zimmer, Inc.·00889024231290·

    PERSONA® Persona SoluTion™

    FDA UDI
    Zimmer, Inc.·00889024231306·

    BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK

    FDA 510(k)
    FDA Class 2 ·Radiology

    LNOP MP12 PATIENT CABLE

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·May 15, 2015

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·April 10, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 31, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·May 20, 2008

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018