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    CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978080307·DISTRACTOR 902-336 DBL BARREL OS 18/12MM

    NEOCIF INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018

    MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    C-THRU SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEOCIF INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017

    SINGLE TRIGGER ROTARY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·June 30, 2014

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·January 8, 2013

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 12, 2010

    ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-002. ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-36, Catalog Number: 90-2336-002 (not approved within USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-001. ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-26, Catalog Number: 90-2336-001 (not approved within USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-000 ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-16, Catalog Number: 90-2336-000 (not approved within USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015