BEUDAMED
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    ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869691796·Tray with lid 145x44x25mm

    Arx

    FDA UDI
    Life Spine, Inc.·00190837035457·Awl with Stop

    SENSILASE PAD-IQ

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FRIALIT-2 ESTHETICBASE ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    PROSIMA PELVIC FLOOR REPAIR KIT

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    NATURAL KNEE II CONGRUENT TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·May 31, 2011

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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