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    CUFF PILOT, SURE SEAL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180188839·PITUITARY RONGEUR; CUSHING, 5-1/2" (14CM), ANGL...

    LACTOSORB* 2.0MM SYSTEM TEMPLATE

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036053833·

    Tuttle Forceps

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896103214·Singley Tuttle Forceps Serrated Tip

    NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SKELETAL DYNAMICS STERILIZATION TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·July 27, 2007

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 24, 2018

    ALIGN R URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·May 29, 2013

    RUSCH FOLEY CATHETER, 2-WAY/PED, 3CC, 8FR

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code EZL·May 26, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012