K003411

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FDA UDI

MEDIVATORS INC.·40677964023246·The ENDO CARRY-ON Procedure Kit contains all of...

FDA UDI

Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm

FDA UDI

STRYKER CORPORATION·04546540046598·Precision Thin (9.0 x 0.38 x 11.5mm)

FDA UDI

STRYKER CORPORATION·04546540401892·Micro Dual Cut (9.0 x 0.38 x 11.5mm)

FDA 510(k)

FDA Class 2 ·Radiology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FDA Adverse Event

Malfunction ·SYNTHES MONUMENT·Product code HTO·February 28, 2013

FDA Adverse Event

Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2011

FDA Adverse Event

Malfunction ·BOSTON SCIENTIFIC·Product code MCX·February 21, 2008

FDA Adverse Event

Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·December 4, 2025

FDA Adverse Event

Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·June 22, 2025

FDA Adverse Event

Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·January 6, 2026