BEUDAMED
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    MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR

    FDA 510(k)
    FDA Class 2 ·Dental

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776364281·Extracting Lower Anterior

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036030148·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450214817·

    HARDYDISK, CEPHALOTHIN 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO THE GRIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

    ILIAC SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019

    ENDOPATH** DEXTRUS* SEAL CAP

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·May 2, 2013

    ARIA RADIATION ONCOLOGY

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·April 19, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 5, 2008

    POLARIS SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

    MCKESSON MEDI-LAB HCG COMBO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JHI·August 4, 2009

    POLARIS TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025