BEUDAMED
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    STARLIGHT

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII

    Flexi-Tip

    FDA UDI
    COOK INCORPORATED·00827002140264·Flexi-Tip Ureteral Catheter (Left)

    VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 070 mm

    FDA UDI
    icotec AG·07640172551790·VADER Pedicle System, Rod, Carbon/PEEK, Curved,...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112070·Tap, Cannulated, 5.5 mm

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    Anterior Cervical Interbody Fusion Device

    FDA UDI
    PRECISION SPINE, INC.·00840019921671·ACIF Rasp, Narrow, 2mm Stop (7mm Height)

    ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LASER PERIPHERALS REUSABLE HOLMIUM FIBER

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

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    POLARCATH

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code DQY·March 26, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    ACUVUE OASYS W/HYDRACLEAR

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·March 28, 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