17 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AMICO DH-W35 OPHTHALMOSCOPE SERIES
FDA 510(k)
FDA Class 2
·Ophthalmic
Bernafon
FDA UDI
Bernafon AG·05711584050309·PC7 CPX, VC PS GB PRECISO 7
BIO-EUROLIG INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD.·Product code GCX·May 25, 2012
RECEPTAL 1.5LITER PE/CE WITH (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·August 1, 2011
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
NON-PVC RECEPT. LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
RECEPTAL 1.5 LITER PE/CE WITH (50/CASE)
FDA Adverse Event
Injury
·HOSPIRA LTD.·Product code GCX·November 18, 2010
RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·June 24, 2011
RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·June 24, 2011
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 29, 2018
ALTRX +4 10D 32IDX50OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 29, 2013
VERSA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·August 21, 2008
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016