BEUDAMED
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    MEDTRONIC STRATAVARIUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    DANEK PLATE AND SCREW

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MANUFACTURING·Product code HRS·May 19, 1999

    K041492

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 18, 2021

    ILT 0.014 CATHETER, MODEL C114NL2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FHC MICROTARGETING DRIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENDO CLIP II MED/LRG 10MM PISTOL GRIP

    FDA Adverse Event
    Injury ·COVIDIEN·Product code FZP·April 2, 2013

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·March 31, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code FZW·July 3, 2013

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code FZW·July 24, 2013

    MEGA 2000 PATIENT RETURN ELECTRODE SYSTEM

    FDA Adverse Event
    Injury ·MEGADYNE MEDICAL PRODUCTS·Product code GEI·June 24, 2002

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021

    PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. 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

    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012