8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CryoFreeze Wart and Skin Tag Remover
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Lifelines iEEG
FDA 510(k)
FDA Class 2
·Neurology
MBT CEM KEEL TIB TRAY SZ3
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code NJL·September 12, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2013
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; 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 FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025