17 results
·
19ms
·
Sources: EU EUDAMED, US FDA
UROPAPER EIKEG
FDA 510(k)
FDA Class 2
·Hematology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517367709·CoRoent® Small, 11x13x15mm Lordotic Plus
DynaBridge
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES LCP PROXIMAL HUMERUS PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW LOCKING
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·March 14, 2012
SCREW
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·March 14, 2012
SCREW
FDA Adverse Event
Injury
·SYNTHES OBERDORF·Product code HWC·March 14, 2012
SCREW
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·March 14, 2012
SCREW
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·March 14, 2012
LIBERTY CYCLER
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·March 10, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 24, 2007
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
3.5MM TI LCP® PROXIMAL HUMERU PLATE-STANDARD 3H SHAFT/90MM
FDA Adverse Event
Injury
·SYNTHES RARON·Product code KTW·February 16, 2016
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·August 7, 2014
BLAKE DRAIN UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GBX·March 6, 2018
400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
FDA Enforcement
Class II
·Terminated·ErgoSafe Product LLC dba Prism Medical Services·April 16, 2014
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