41 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776392734·Periosteal Elevator #854, double-ended, round h...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720493·Jeweler Forceps #5, super fine, 4-3/8" (10.9cm)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450333273·
EFILM WORKSTATION WITH MODULES
FDA 510(k)
FDA Class 2
·Radiology
SHIKANI SPEAKING VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
CUSTOM TKR
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
SPECIAL TKR
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 SMILES TKR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOM SMILES TKR
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
SPECIAL TOTAL KNEE REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 24, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 20, 2013
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·June 13, 2011
TRIAGE CARDIO PROFILER TEST
FDA Adverse Event
Malfunction
·BIOSITE, INCORPORATED·Product code MMI·August 16, 2008
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
TOTAL KNEE REPLACEMENT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·January 25, 2018
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
CUSTOM SMILES TOTAL KNEE REPLACEMENT (TKR)
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014
CUSTOM DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014