BEUDAMED
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    NEW COBE SATURATION/HEMATOCRIT MONITOR

    FDA 510(k)
    FDA Class 2 ·Hematology

    ORA Implant Abutment 2.0mm Cuff (A)

    FDA UDI
    STERNGOLD DENTAL LLC·00841549110993·Implant Interface design varies, dependent upon...

    V SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASI HEMOSTASIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 24, 2020

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code KFM·June 26, 2014

    SPRINT RV

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·January 9, 2013

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC. USA·Product code LFR·October 26, 2007

    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