8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
FDA 510(k)
FDA Class 1
·General Hospital
Fluent Inflation Device
FDA 510(k)
FDA Class 2
·Cardiovascular
11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·August 17, 2018
COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 5, 2014
SPINBRUSH PROCLEAN POWERED TOOTHBRUSH
FDA Adverse Event
Malfunction
·CHURCH & DWIGHT CO., INC.·Product code JEQ·November 13, 2012
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 18, 2015
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems
FDA Enforcement
Class II
·Terminated·GE Healthcare·April 1, 2015