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33 catalysts · 18 device 510k · 8 device pma · 4 approval · 3 device recall
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33 catalysts · 18 device 510k · 8 device pma · 4 approval · 3 device recall
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Supplement type: Normal 180 Day Track No User Fee. Product code: OZD. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: PYX. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
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. — Reason: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost. — Status: Ongoing
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059. — Reason: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost. — Status: Ongoing
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 722011. 7. Allura Xper FD20, Model Number 722012. 8. Allura Xper FD20 Biplane, Model Number 722013. 9. Allura Xper FD20 OR Table, Model Number 722023. 10. Allura Xper FD10, Model Number 722026. 11. Allura Xper FD10/10, Model Number 722027. 12. Allura Xper FD20, Model Number 722028. 13. Allura Xper FD20/10, Model Number 722029. 14. Allura Xper FD20 OR Table, Model Number 722035. 15. Allura Xper FD20/20, Model Number 722038. 16. Allura Xper FD20/15, Model Number 722058. 510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859. — Reason: Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. — Status: Ongoing
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NDW. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: MQC. Advisory committee: Unknown. Type: Traditional
Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HTY. Advisory committee: Orthopedic. Type: Traditional
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LRX. Advisory committee: Ophthalmic. Type: Traditional
Product code: KPE. Advisory committee: General Hospital. Type: Special
Product code: MMI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: NOM. Advisory committee: Microbiology. Type: Traditional
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Product code: LJS. Advisory committee: General Hospital. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EGM. Advisory committee: Dental. Type: Traditional