11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fundus Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017934·K-Wire, Double Ended, Trocar Point, Diameter Si...
ATLAS WOUND MATRIX
FDA 510(k)
FDA Unclassified
·Unknown
ADAPT, MODEL AX-03SN
FDA 510(k)
FDA Class 1
·Ophthalmic
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 28, 2019
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 21, 2014
SIGNATURE PLANNER; SIGNATURE GUIDES
FDA Adverse Event
Other
·MATERIALISE NV·Product code JWH·June 21, 2013
MITEK VAPR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code GEI·August 4, 2011
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 28, 2019
RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014