18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iBond Universal & iBond Ceramic Primer
FDA 510(k)
FDA Class 2
·Dental
CONSENSUS CS2 PLUS ACETABULAR INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
FDA 510(k)
FDA Class 2
·Ophthalmic
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·January 7, 2016
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 6, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 3, 2008
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
NESTER PLATINUM EMBOLIZATION MICROCOIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
STAINLESS STEEL EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·August 24, 2017
VITAL-PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·May 24, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018