BEUDAMED
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    DISPOSABLE CORONARY CONTROL SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012

    SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WIRE, GUIDE, CATHETER, MODEL QSW1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·January 8, 2013

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    FDA Adverse Event
    Malfunction ·AMERICAN OPTISURGICAL, INC.·Product code LFL·February 24, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·November 11, 2010

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

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

    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