9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
FDA 510(k)
FDA Class 2
·Hematology
BEAMSCAN
FDA 510(k)
FDA Class 2
·Radiology
SPI ART ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
TITANIUM SCREW LOW PROFILE 5X40MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016
TITANIUM SCREW LOW PROFILE 5X40MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·February 14, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·January 14, 2011
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 28, 2014
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026