BEUDAMED
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    IRON REAGENTS PRODUCT CODES 7725 AND 7726

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020

    FDA 510(k)
    FDA Class 2 ·Immunology

    RIGID GAS PERMEABLE CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BALL HEADS: BIPOLAR HEAD 25060.2844 BIPOLAR HEAD Ø28X44

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·February 16, 2023

    S-ICD SYSTEM

    FDA Adverse Event
    Malfunction ·CAMERON HEALTH INC·Product code NVY·May 7, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·January 8, 2013

    ACTIVA PC

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 12, 2010

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021