BEUDAMED
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    CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GIGLI SAW SOLID HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896047921·GIGLI SAW SOLID HANDLE

    EPAD

    FDA UDI
    SAFEOP SURGICAL, INC.·00851641007190·EPAD Peripheral Electrode Pouch Kit

    Oticon

    FDA UDI
    Oticon A/S·05707131153982·AGIL PRO, MINIRITE DBL DEMO L

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001249·Inset 1 Level ACP, 8mm

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361000099·Arena-L, Lordotic 10 degrees, 35X26X08

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471155684·V Nat D 018 Lo

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THERMOFLEX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981307394·25° M/L Angled Box Cutter, 08 x18mm

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327102079·Posterior Stabilized Tibial Insert

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00840326425244·NiTi SE Archwire, NAT .018 Lower Dimple 10EA

    AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 16, 2011

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 8, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 13, 2011

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·August 5, 2008

    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 5, 2015

    Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit 510141-BP,10" fenestrated catheter& BIOPATCH Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012