BEUDAMED
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    Control-IQ Technology

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VASCULAR HEMOSTATIC FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896091344·VASCULAR HEMOSTATIC FORCEPS CURVED TIP

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113509·MINIATURE BLADE #67 (BX/5)

    ACUMED

    FDA UDI
    Acumed LLC·10806378014406·3.5mm x 65.0mm Locking Cortical Screw

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450155370·

    ACUMED

    FDA UDI
    Acumed LLC·10806378014413·3.5mm x 65.0mm Locking Cortical Screw

    URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNK_SMART TOUCH UNIDIRECTIONAL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·August 23, 2022

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    FDA Adverse Event
    BAXTER HEALTHCARE·Product code KDJ·October 2, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 27, 2018

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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