BEUDAMED
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    STERI-VAC GAS STERILIZER MODEL 5XL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HOTWIRE™ RF GUIDEWIRE

    FDA UDI
    Atraverse Medical, Inc·00850057445619·The HOTWIRE™ is a sterile, single-use guidewire...

    OMEGA

    FDA UDI
    Stryker GmbH·07613154482405·Upper Instrument Tray

    OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DOCTOR SURGERY DIODE LASERS FAMILY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    YPSOPUMP INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·February 13, 2025

    MBT CEM KEEL TIB TRAY SZ2.5

    FDA Adverse Event
    Injury ·DEPUY IRELAND ? REG. # 9616671·Product code NJL·January 8, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·November 10, 2010

    DISTAL FIBULA PLATE HOLES 6 LENGTH 117MM FOR SCREWS 3.5/4.0MM

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HRS·June 30, 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