13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295253686·LARGE BLADE DEEP
C50 and C80 Multi-parameter Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUIA
FDA 510(k)
FDA Class 2
·Dental
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 6, 2013
CRYSTALENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·February 11, 2011
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024