BEUDAMED
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    AUDIOSCREENER OAE+ABR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Cook

    FDA UDI
    COOK INCORPORATED·00827002140523·Round Tip Ureteral Catheter (Left)

    Round Tip

    FDA UDI
    COOK INCORPORATED·00827002172371·Round Tip Ureteral Catheter (Left)

    CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SYNERGY

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LGW·March 27, 2013

    BLOOD GROUPING REAGENT ANTI-A (ABO1)

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·February 1, 2011

    HEARTPORT VENT CATHETER

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code DWF·March 27, 2008

    Portex High Pressure 1 - Way Stopcock Catalog Number: T8200

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004

    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