8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FLASH-LITE LED DENTAL CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
ECG CHECK
FDA 510(k)
FDA Class 2
·Cardiovascular
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 23, 2014
RUSCH ROBERTSHAW EB TUBE, RIGHT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code JOH·January 16, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025