BEUDAMED
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    LERADO, POWER WHEELCHAIR, PB

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517128089·MAS PLIF Tap, 5.5mm Extended

    PBN HYSTERO-SALPINGOGRAPHY CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIGACLIP** ENDOSCOPIC

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 22, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 19, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 3, 2008

    Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·August 26, 2020

    BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·October 30, 2013

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024