BEUDAMED
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    ONLINE DAT II METHADONE II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PAQ.215X280X100.HP M3707A

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763010555·

    Healqu

    FDA UDI
    Healqu LLC·00819143020376·HEALQU Waterproof Adhesive Border Foam Dressing...

    18M - Loggers - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal

    SOPRO595 INTRA ORAL CAMERA

    FDA 510(k)
    FDA Class 1 ·Dental

    IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLYMPUS CARBON DIOXIDE INSUFFLATOR

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code HIF·March 12, 2013

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·February 16, 2011

    AFFINITY 3

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·March 26, 2008

    Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument

    FDA Recall
    Terminated ·Premier Dental Products Co·Product code GEH·April 29, 2004

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015