BEUDAMED
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    RAPICIDE OPA-28 TEST STRIP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Shannon Recta Round Shank

    FDA UDI
    Gebr. Brasseler GmbH & Co. KG·14053613289587·

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030993·SPEC LP GOWN, X-LG W/PAP TWL

    M-Flex®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020166·Blue Silicone Tungsten Maloney Esophageal Dilat...

    Logical Cup Liner

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215054175·

    Logical 20° Hooded Liner

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215009434·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111206520·Liner, 36-52/54mm (20° Hood)

    HERNIAMESH T-SLING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACL TIGHTROPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENTO XLPE Liner

    FDA UDI
    AMPLITUDE SAS·03701089514606·

    ARTHROSCOPE

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·May 20, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·June 10, 2011

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015