9 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Arrow Endurance Extended Dwell Peripheral Catheter System
FDA 510(k)
FDA Class 2
·General Hospital
Sklar®
FDA UDI
SKLAR CORPORATION·10649111282683·TC METZ SCISS STR DEL B/B 5.75
Custom Leg Adapter Puller
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215137410·
ECHELON MR-RCC-150 CARDIAC COIL
FDA 510(k)
FDA Class 2
·Radiology
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA
FDA 510(k)
FDA Class 2
·Orthopedic
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 11, 2013
OASIS DRY SUCTION CHEST DRAIN
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORP.·Product code KDQ·June 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 10, 2014
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