7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
FDA 510(k)
FDA Class 2
·Neurology
PERITONEAL CATHETER-CHANGES-
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 11, 2010
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 10, 2012
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