8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BLADDERSCAN BVI 2500
FDA 510(k)
FDA Class 2
·Radiology
NOBELPHARMA DRILLING EQUIPMENT DEC 500
FDA 510(k)
FDA Class 2
·Dental
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 18, 2014
TC3 RP TIBIAL INSERT S2.5,10.0
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code NJL·January 22, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
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