12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDICINAL LEECHES
FDA 510(k)
FDA Unclassified
·Unknown
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHILIPS AVALON FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMP TM 4.7MM MTX FULL, 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 27, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·October 1, 2014
GREENLIGHT HPS FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 16, 2013
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·June 17, 2011
IMP TM 4.7MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 30, 2024
IMP TM 6.0MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 29, 2023
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023