7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
FDA 510(k)
FDA Class 2
·Immunology
FLEXCOMP DSP & PROCOMP
FDA 510(k)
FDA Class 2
·Neurology
SCD THERAPEUTIC STOCKING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·January 9, 2013
SONICAID
FDA Adverse Event
Death
·HUNTLEIGH HEALTHCARE LTD DIAGNOSTICS·Product code HGM·November 8, 2010
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015