8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
UNIVERSAL CUSHIONED METAL EYE SHIELD
FDA 510(k)
FDA Class 1
·Ophthalmic
VARIAX
FDA UDI
Stryker GmbH·07613327177299·Upper Tray
MHLX7EC TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
DISPOSABLE ENDOSCOPIC CANNULA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 24, 2015
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·December 23, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020