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Blue Sky Bio, LLC

FDA UDI
BLUE SKY BIO LLC·00815131021783·

CLASS OF CASTING ALLOYS TYPE I OR ALTER

FDA 510(k)
FDA Class 2 ·Dental

ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II

FDA 510(k)
FDA Class 2 ·Hematology

O-ARM IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·February 4, 2019

Dual barrel syringe root canal intraoral tip IOR 209-20

FDA UDI
Vista Dental·10818207023855·

O2

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·April 4, 2019

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 19, 2012

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 12, 2012

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 4, 2012

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 26, 2012

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 31, 2012

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 17, 2012

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 18, 2012

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 25, 2014

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 22, 2013

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION·Product code HAW·December 1, 2010

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 21, 2014

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·August 29, 2011

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION·Product code HAW·December 7, 2010

STEALTHSTATION IOR SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 21, 2011