BEUDAMED
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    RADIOGRAPHIC FILM CASSETTES

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIGMA

    FDA UDI
    DEPUY (IRELAND)·10603295242178·SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE ...

    Contour Next EZ Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SENSOR BSA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·February 14, 2013

    UNKNOWN DEPUY PATELLA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTG·January 7, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2014

    TC3 RP TIBIAL INSERT S2.5,22.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code NJL·September 18, 2019

    ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric chemistry analyzer for clinical use and is classified as a Class I (general control) device. --- The ADVIA Centaur CP is part of Bayer's Immunochemistry analyzer family, which also includes the ADVIA Centaur and the ACS:180. Based on FDA guidance for deciding when regulatory filings are warranted for device modifications, as well as, the FDA Instrument Family and Replacement Reagent Policy Guidance, Bayer determined that the changes associated with the ADVIA Centaur CP did not affect the safety and effectiveness of the predicate device (ACS:180) and therefore no device modification 510(k) was warranted. The ADVIA Centaur CP instrument uses the same reagents as the ADVIA Centaur. The ACS:180 was cleared by FDA under 510(k) # K902336, and the ADVIA Centaur was cleared by FDA under 510(k) # K971418. The ADVIA Centaur CP system was released for sale in November 2005 and distribution of these systems began at that time. All ADVIA Centaur CP Systems are impacted. There is no expiration date for these systems.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JJE·November 9, 2006