BEUDAMED
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    Lockheed - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal

    Vitra 810

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    K2 OPAQUER powder, O-A2, 15g.

    FDA UDI
    Yeti Dentalprodukte GmbH·EYET3201502·

    QUIKFLAP, UNIVERSAL NEURO 2

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154619849·2 HOLE PLATES(3) SELF DRILLING SCREW(6)

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153152965·TROCAR HANDLE FOR 2.0MM SCREWS

    BOWL 6 L WITH DRAINAGE 201502

    FDA UDI
    Merivaara Oy·06438435015025·Operating table accessory

    OSCAR, MODEL OE3000

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·June 2, 2023

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 3, 2023

    BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 25, 2018

    TRIFECTA STENTED TISSUE VALVE, IDE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL CANADA, INC.·Product code LWR·June 28, 2013

    8100

    FDA Adverse Event
    Malfunction ·ALARIS·Product code FRN·August 3, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·October 27, 2014

    RADIFOCUS GUIDEWIRE M

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 4, 2016

    Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

    FDA Enforcement
    Class I ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014

    Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

    FDA Enforcement
    Class I ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014

    Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·October 15, 2014

    Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 28, 2014

    FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

    FDA Enforcement
    Class I ·Terminated·Abbott Diabetes Care, Inc.·December 25, 2013