30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
FDA 510(k)
FDA Class 2
·Cardiovascular
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112786·BARRON VACUUM PUNCH 8.25MM
Explorer TO
FDA UDI
Seaspine Orthopedics Corporation·10889981307066·9mm Trial, 11mm Height
SPIRA®-P Integrated Fixation System
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SP1021090·SP-102-109, Posterior Trials
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021090·SPIRA®-A Integrated,Trial, 28x32mm, 20° Lordoti...
COVERIS
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CS1021090·Trial, 12.5mm x 16mm Lordotic 7, 9mm
NIAGARA® Lateral Access System
FDA UDI
VB Spine LLC·10888857520004·Straight Blade, Size 20x130 mm
OLEEVA FOAM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DRI ECSTASY URINE CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 29, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 16, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 20, 2016
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 23, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 20, 2011
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·January 15, 2021
SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
FDA Adverse Event
Death
·ETHICON INC.·Product code LMG·May 27, 2021
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·June 2, 2021
LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FZP·June 2, 2021
SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·May 27, 2021