11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION
FDA 510(k)
FDA Class 2
·Dental
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111017·SILICONE MAT FOR INSTRUMENT CADDY
AART SILICONE CARVING BLOCK
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INWAVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TAPERLOC COMPLETE PRIMARY FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·February 20, 2025
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·January 18, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 7, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 9, 2014
MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024
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