10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS
FDA 510(k)
FDA Class 1
·Dental
Sklar®
FDA UDI
SKLAR CORPORATION·10649111085550·JEWETT URETHRAL SOUND 24FR 9.5
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209105779·
Arch Hook
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746147074·ARCH HOOK WELDABLE 2MM 040 ROUND 10/PKG
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
AngioDynamics Mariner Angiographic Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 5, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 29, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 29, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015