K014113

FDA 510(k)

FDA Class 2 ·Neurology

FDA UDI

Kalitec Direct LLC·B07323K0101130·Distractor, Smooth Paddle, Lordotic, 13mm

FDA UDI

GRI Medical & Electronic Technology Co., Ltd.·16931918175799·Underbuttock Drape with Pouch_32x45in_Sterile_7...

FDA UDI

Kalitec Direct LLC·B07312K0101130·Distractor, Smooth Paddle, 13mm

FDA UDI

Inspecs U.S.A., L.C.·00841543148718·SUNGLASS

FDA UDI

Kalitec Direct LLC·B07330K0142130·Trial, TLIF, 32L OB CRV 7Deg, 13mm

FDA UDI

Kalitec Direct LLC·B07330K0144130·Trial, TLIF, 32L OB STR 7Deg, 13mm

FDA UDI

Phonak AG·07613275086605·Phonak Naída Q90-RIC (pure transparent)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FDA Adverse Event

Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NVY·April 30, 2019

FDA Adverse Event

Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

FDA Adverse Event

Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

FDA Adverse Event

Other ·B. BRAUN MEDICAL, INC.·Product code FMI·March 13, 2008