12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wondfo One Step Fecal Occult Blood (FOB) Test
FDA 510(k)
FDA Class 2
·Hematology
BI-METRIC(R) HEAD/NECK PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307254·
LAIMAD
FDA 510(k)
FDA Class 2
·Dental
LRT ATTACHMENT
FDA 510(k)
FDA Class 2
·Dental
ATTAIN PERFORMA STRAIGHT MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·October 10, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 11, 2013
INFUSION PUMP MOUNT (POST MOUNT)
FDA Adverse Event
Death
·MODULAR SERVICES COMPANY·Product code FOX·May 10, 2011
MEDTRONIC
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·May 22, 2020
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 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