K040066

FDA 510(k)

FDA Class 2 ·Radiology

FDA UDI

Elekta Solutions AB·07340201501870·ARC SUPPORT RIGHT

FDA UDI

Merit Medical Systems, Inc.·00884450148518·

FDA UDI

SUNTECH MEDICAL, INC.·10840935103363·

FDA UDI

ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311138·

FDA 510(k)

FDA Class 2 ·Orthopedic

FDA 510(k)

FDA Class 2 ·Hematology

FDA Adverse Event

Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·April 3, 2013

FDA Adverse Event

Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 25, 2011

FDA Adverse Event

Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·May 7, 2008

FDA Enforcement

Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026