33 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
FDA 510(k)
FDA Class 2
·Immunology
K121116
FDA UDI
Life Spine, Inc.·00190837016029·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016043·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016258·
CHS
FDA UDI
Smith & Nephew, Inc.·03596010062291·AMBI COMPRESSION HIP SCREW PLATE 12SL 260MM 135D
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974032·UniTip High Resolution Catheter 12F
PUREIMAGE ULTRASOUND TRANSMISSION GEL
FDA 510(k)
FDA Class 2
·Radiology
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
CUSTOM PROXIMAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOMER PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code JWH·January 8, 2015
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 20, 2013
FLIXENE GRAFTS
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code DSY·September 24, 2014
CORE UNIVERSAL DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·May 4, 2011
CUSTOM DISTAL FEMORAL IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
UNK- NON- STANMORE HIP REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code KRO·June 25, 2015
CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
PROXIMAL FEMUR
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 19, 2014
CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·July 1, 2015
CUSTOM MID-SHAFT FEMUR
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014