BEUDAMED
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    OLYMPUS OES OTV-S5C VIDEO SYSTEM

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

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994184153·CASE 6971416 PRESTG LP 6MM UPR INSRT TRY

    PEEK Corpectomy

    FDA UDI
    Nuvasive, Inc.·00887517623713·PEEK Corp Core, Ø14x16mm

    IRRIGATION/ASPIRATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code HWC·December 18, 2015

    ADVIA CENTAUR RUBELLA G (RUB G) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LFX·March 26, 2013

    S3 EX - 3005

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 21, 2013

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 31, 2014

    PLM A+3 MEDNET WRLSS

    FDA Adverse Event
    Injury ·HOSPIRA, INC.·Product code FRN·January 12, 2011

    ADVIA CENTAUR XPT

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 19, 2016

    ZONA PLUS

    FDA Adverse Event
    Injury ·ZONA HEALTH·Product code BXB·March 25, 2013

    ADVIA CENTAUR XP

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code NHS·January 31, 2014

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZO·December 4, 2014

    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