BEUDAMED
    55 results · 12ms · Sources: EU EUDAMED, US FDA

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    ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.

    FDA Enforcement
    Class II ·Terminated·Data Innovations, LLC·September 24, 2014

    Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

    Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

    Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

    Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam Perfecta w/ rose/gray enclosure and rose colored display

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

    Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

    Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

    Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates

    FDA Recall
    Terminated ·Pml Microbiologicals Inc.·Product code JSO·August 17, 2007

    Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FMG·April 17, 2007

    Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only-103.5ml (3.5 fl. oz.) can. Product Number 0386-0008-02)

    FDA Recall
    Terminated ·Gebauer Company·Product code MLY·April 17, 2007

    Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only. 103.5ml (3.5 fl. oz.) can-(Product Number-0386-0008-03)

    FDA Recall
    Terminated ·Gebauer Company·Product code MLY·April 17, 2007

    Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container, Rx only, 30 mL(1.0 fl. oz.) can.-(Product Number-0386-0008-01)

    FDA Recall
    Terminated ·Gebauer Company·Product code MLY·April 17, 2007

    Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP, Merit Medical Systems, South Jordan, Utah.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FMG·April 17, 2007

    Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml) can-(Product Number-0386-0010-01)

    FDA Recall
    Terminated ·Gebauer Company·Product code MLY·April 17, 2007

    Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FMG·April 17, 2007

    Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FMG·April 17, 2007

    Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries. 3.5 fl. oz. (103.5ml) can.-(Product Number: 0386-0010-05-)

    FDA Recall
    Terminated ·Gebauer Company·Product code MLY·April 17, 2007

    Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FMG·April 17, 2007

    Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04

    FDA Recall
    Terminated ·Gebauer Company·Product code MLY·April 17, 2007

    Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.

    FDA Recall
    Terminated ·Gambro BCT, Inc.·Product code LKN·September 18, 2007