10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)
ULTRASOUND SCANNER PRO FOCUS 2202
FDA 510(k)
FDA Class 2
·Radiology
UNITY NETWORK IS PATIENT VIEWER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
EASYTRAK
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWP·November 6, 2014
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011
U BY KOTEX CLINCK
FDA Adverse Event
Malfunction
·AVENT SA DE R.L. DE C.V.·Product code HEB·December 11, 2012
TRULIANT TIB IMP CR INS SLOPE+ SZ 4.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 29, 2024
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