BEUDAMED
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    HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER

    FDA 510(k)
    FDA Class 2 ·Immunology

    PORTUX CAD/CAM Disc. 98.5X 18mm A3. ML

    FDA UDI
    PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126710103·PORTUX CAD/CAM Disc. 98.5X 18mm A3. ML

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM

    LORENZ RESORBABLE DISTRACTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PEN NDL 32G 4MM 100BX 1200 USA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 1, 2021

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 26, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·February 28, 2011

    CARDIOMAPPING SYSTEM

    FDA Adverse Event
    Injury ·BIOSCIENCE WEBSTER·Product code HAW·March 27, 2008

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018