7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDI - PUMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
2620/1 TO 2635/2 VARIOUS DENTAL CROWN SCISSORS
FDA 510(k)
FDA Class 1
·Dental
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 9, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 6, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 23, 2014
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