11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTURA CAVITY MAINTENANCE CATHETER
FDA 510(k)
FDA Class 2
·Radiology
PolyLock Small Bone Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
MICRO INCISION VACUUM PACK
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQC·March 1, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011
CAPSUREEPI
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·August 8, 2014
GORE DUALMESH BIOMATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTL·July 26, 2019
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025