BEUDAMED
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    24-HOUR URINE COLLECTION COOLING WRAP

    FDA 510(k)
    FDA Class 1 ·Pathology

    PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFINITY Total Ankle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 30, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·October 10, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 22, 2007

    7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later

    FDA Recall
    Terminated ·Picis Inc.·Product code NSX·March 8, 2010

    Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.

    FDA Recall
    Terminated ·Picis Inc.·Product code NSX·August 1, 2011

    Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.

    FDA Recall
    Terminated ·Picis Inc.·Product code NSX·August 12, 2011

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024