8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EMIT CAFFEINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209123421·
EMERGENCY TRACHEOSTOMY KIT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SAV-A-LIMB
FDA 510(k)
FDA Class 1
·General Hospital
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 16, 2014
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 3, 2012
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 7, 2010
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 16, 2018