10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SCAN WHITE 12 ML
FDA 510(k)
FDA Class 2
·Dental
VERTEX® Reconstruction System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074239170·BONE SCREW 6955406 4.0 X 6MM CORTICAL
Coulmed
FDA UDI
Coulmed Products Group LLC·10810087350328·Standard Sterile Surgical Gown, with Towel, Lar...
Arthrex®
FDA UDI
ARTHREX, INC.·00888867406544·Trial Humeral Spacer 33 +6mm
DAVOL ELECTROSUGICAL PROBES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OSTEONICS HIP REVISION WEDGES
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 11, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 24, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 10, 2011
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