89 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Grid Biopsy Unit single use medial Breast BI 7
FDA UDI
Noras MRI products GmbH·04251269207037·The intended use of Breast BI 7 MR Coil Set 1.5...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515234277·Hardy Bay Fcps, 2.0mm tip, insul, 8 1/2"
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970379·
SHIMADZU COLLIMATOR R-300
FDA 510(k)
FDA Class 2
·Radiology
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·February 6, 2015
METS MODULAR DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
CUSTOM DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 20, 2015
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 13, 2015
CUSTOM DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·May 15, 2015
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 20, 2015
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 16, 2015
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 26, 2014
BIOFINITY SPHERE (COMFILCON A)
FDA Adverse Event
Injury
·COOPERVISION MANUFACTURING LIMITED·Product code LPM·June 9, 2011