BEUDAMED
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    HALL MODULAR ACETABULAR REAMER SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HALO MOLAR BAND

    FDA UDI
    Ortho Arch Company Inc·D90990233216·L7L HALO MOLAR BAND .022 SGL NON-CV -25T BT

    EEG SPIKE AND EVENT DETECTOR MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 14, 2020

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014

    PINN SECTOR W/GRIPTION 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·January 8, 2013

    PUMP MMT-715NAP PRDGM INS V2.1 PL EN

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