BEUDAMED
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    LIAISON PLEX Respiratory Flex Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551082126·Elevator, sharp, 4 mm, 18 cm

    SMALL BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919094272·KM33-410

    Brasseler USA

    FDA UDI
    Provision·00810041064950·

    Reprocessed Small Bone Oscillating Saw Blade, 11.5 x 5.5 x 0.56mm

    FDA UDI
    SURETEK MEDICAL·B390KM334101·

    NA

    FDA UDI
    STERILMED, INC.·10888551017121·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...

    Camera Sterilization Tray

    FDA UDI
    PARAGON MEDICAL, INC.·00857387006022·Camera Sterilization Tray

    TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·November 6, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 2, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013

    CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas.

    FDA Enforcement
    Class II ·Terminated·Metrex Research, LLC.·September 5, 2012