7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S-357 VIDEO IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
INTERNATIONAL MODEL XP BEHIND-THE-EAR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NATRELLE STYLE 110 REF #110-300
FDA Adverse Event
Injury
·ALLERGAN·Product code FWM·February 13, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·January 17, 2011
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·August 1, 2014
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. 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