9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IN VITRO T3 RIA TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 7, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 8, 2010
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·December 6, 2012
ATTUNE PS RP INSRT SZ10 6MM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·December 19, 2019
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