42 results
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70ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CFLEX POLAR HD POS DEVICE ONLY
FDA Adverse Event
Malfunction
·ALLEN MEDICAL SYSTEMS·Product code CCX·May 1, 2024
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 17, 2011
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIM·August 23, 2012
WATCHMAN FLX? PRO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·August 9, 2024
WATCHMAN FLX? PRO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·February 27, 2026
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
FDA Recall
Open, Classified
·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku·Product code IYB·April 10, 2023
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
FDA Enforcement
Class II
·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·August 9, 2023
EVIS EXERAIII BRONCHOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code EOQ·August 4, 2016
EVIS EXERAIII BRONCHOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code EOQ·August 4, 2016
WATCHMAN FLX? PRO
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·March 9, 2026
EVIS EXERAIII BRONCHOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code EOQ·August 4, 2016
ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code FCW·July 17, 2017
GLENOID SCR EPOCA Ø3.5 L24 TAV
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code KWT·August 7, 2014
HD CAMERA HEAD
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·May 1, 2024
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·August 27, 2012
GLENOID SCR EPOCA Ø3.5 L10 TAV
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code KWT·August 7, 2014
8.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·April 2, 2013
DURASUL®, ALPHA INSERT, MM/36
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWA·March 11, 2022
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·October 8, 2010
GLENOID SCR EPOCA Ø3.5 L24 TAV
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code KWT·August 7, 2014