BEUDAMED
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    SERRALENE, MODEL CATALOG NO 1S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Safco Illusion Plus Composite

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310202653·Safco Illusion Plus A2 Syringe 4g

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120202651·Carbide - Excavating and fissure burs

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·00843717102632·Mirror Handles CS Octagonal

    Kinesia 360

    FDA UDI
    Great Lakes Neurotechnologies Inc.·00859584006089·Kinesia 360, Sensor Lower

    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    WHEELCHAIR COMPONENTS

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code KNN·March 25, 2013

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·March 11, 2011

    MBT CEM KEEL TIB TRAY SZ3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC., DEPUY-CORK·Product code NJL·March 25, 2008

    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