BEUDAMED
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    EQUALIZER BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 26, 2013

    TECNIS MULTIFOCAL IOL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS,·Product code HQL·March 9, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008

    M2A-MAGNUM 52-60MM TPR INSRT-6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    M2A-MAGNUM PF CUP 64ODX58ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    M2A-MAGNUM 52-60MM TPR INS STD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    M2A-MAGNUM PF CUP 62ODX56ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    INCLUSIVE TAPERED IMPLANT 3.2 MMD X 11.5 MML X 3.0 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 19, 2020

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    INTEGRAL/X LAT POR PROFILE 9MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·October 29, 2012

    M2A-MAGNUM 52-60MM TPR INSRT-6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 29, 2012

    M2A-MAGNUM PF CUP 60ODX54ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 29, 2012

    M2A-MAGNUM MOD HD SZ 58MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 29, 2012

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014