9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXACTECH STERILE MODULAR DRILL BIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295233763·P.F.C. SIGMA CEMENTED FEMORAL STEM 13mm x 90mm ...
Carriere Motion Clear Class II
FDA 510(k)
FDA Class 2
·Dental
CURATIVE DENTAL ACRYLIC TEETH
FDA 510(k)
FDA Class 2
·Dental
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 25, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP·Product code LZG·December 16, 2010
ILASIK
FDA Adverse Event
Injury
·Product code LZS·July 22, 2014
PFCSIG CEM FEM STEM 5DG13X90MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·February 4, 2025
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016