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SFA MODULE

FDA 510(k)
FDA Class 2 ·Cardiovascular

Safe-Flo™

FDA UDI
HU-FRIEDY MFG. CO., LLC·10889950134051·Safe-Flo Plus Sample Pack

POTENZA Tip

FDA UDI
Jeisys Medical Inc.·08800020106308·POTENZA Tip (SFA Tip)

SFA-II MICROPROCESSOR-CONTROLLED MODULE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SmartFrame Array

FDA UDI
Clearpoint Neuro, Inc.·00850359007935·SmartFrame Array Thumbwheel Extension

SMARTFrame Array

FDA UDI
Clearpoint Neuro, Inc.·00850376007710·SmartFrame Array Offset & Center Guides, 5.4mm

B80088121SFA100MLF0

FDA UDI
UTAK LABORATORIES, INC.·B80088121SFA100MLF0·B80088121SFA100MLF0

Array

FDA UDI
Clearpoint Neuro, Inc.·00850376007604·SmartFrame Array - MR Drilling Kit

Array

FDA UDI
Clearpoint Neuro, Inc.·00850376007635·SMARTFrame Array MR Drilling Procedure Kit

Array

FDA UDI
Clearpoint Neuro, Inc.·00850376007628·SMARTFrame Array MR Burr Hole Procedure Kit

Array

FDA UDI
Clearpoint Neuro, Inc.·00850376007611·SMARTFrame Array OR-MR Procedure Kit

SmartFrame Array

FDA UDI
Clearpoint Neuro, Inc.·00850359007928·SmartFrame Array Guide Tube Kit

SmartFrame Array

FDA UDI
Clearpoint Neuro, Inc.·00850376007598·SmartFrame Array - MR Burr Hole Kit

SmartFrame Array

FDA UDI
Clearpoint Neuro, Inc.·00850359007904·SmartFrame Array with SNS Adapters

COMPLETE SE SFA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIP·October 25, 2016

COMPLETE SE SFA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIP·December 2, 2016

COMPLETE SE SFA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIP·May 26, 2014

COMPLETE SE SFA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIP·October 17, 2017

COMPLETE SE SFA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIP·August 14, 2015

COMPLETE SE SFA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIP·December 8, 2017