16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
WILKENS CHALGREN AGAR
FDA 510(k)
FDA Class 2
·Microbiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756600538·Electrode, Lletz
VERTEBRON SSP CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
API ZYM
FDA 510(k)
FDA Class 1
·Microbiology
FLOEY CATHETER W TEMP
FDA Adverse Event
Injury
·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·May 30, 2014
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·October 20, 2010
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·December 17, 2012
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
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 Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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