BEUDAMED
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    ULTRASONIC SCALER ELEGANCE MS-10 (25K)

    FDA 510(k)
    FDA Class 2 ·Dental

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700617·Locke Elevator 5" (12.5cm), large blade, 5 x 20mm

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102045·SS Suture, 5 per sleeve

    APNOESCREEN PRO, ALPHA SCREEN PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    C. NET 2100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 8, 2013

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·May 7, 2008

    ADVIA 1650

    FDA Adverse Event
    SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·April 5, 2011

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014

    PKG, COBRA FORCEPS, P/N 0250080317. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HSB·November 7, 2013

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part

    FDA Enforcement
    Class I ·Terminated·Tenacore LLC·April 14, 2021