K063416

FDA 510(k)

FDA Class 2 ·Ophthalmic

FDA UDI

Kalitec Direct LLC·B07330K0134160·Trial, TLIF, 27L OB STR 7Deg, 16mm

FDA UDI

MEASUREMENT SPECIALTIES, INC.·H29780010634160·8001 Series Foley Catheter Temperature Probe, 1...

FDA 510(k)

FDA Class 2 ·Orthopedic

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FDA Adverse Event

Malfunction ·ZIMMER SURGICAL·Product code GFD·April 12, 2013

FDA Adverse Event

Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·April 19, 2011

FDA Adverse Event

Injury ·EDWARDS LIFESCIENCES·Product code LWR·June 19, 2008

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

FDA Adverse Event

Malfunction ·RESPIRONICS INC·Product code CBK·August 19, 2020

FDA Adverse Event

Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026