18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zeta Cranial Navigation System (ZNS131-US)
FDA 510(k)
FDA Class 2
·Neurology
Evolve Masters
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002299·
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051921·
25-Hydroxy Vitamin Ds EIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Revolution Peripheral Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 23, 2013
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
G7 SCREW 6.5MM X 35MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·July 22, 2025
G7 SCREW 6.5MM X 20MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·July 22, 2025
G7 OSSEOTI 3 HOLE SHELL 50MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 22, 2025
HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT
FDA Adverse Event
Death
·MAQUET CARDIOVASCULAR, LLC.·Product code DSY·April 20, 2010
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT
FDA Adverse Event
Death
·MAQUET CARDIOVASCULAR, LLC·Product code DSY·April 20, 2010