9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MITEK G III ANCHOR, MITEK LS ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
JAW INS. BULLET NOSE GRASPER 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SUPER TAMPAX TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
INFERIOR END PLATE MEDIUM-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·February 6, 2013
2124215-2010-19722
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NVZ·January 3, 2011
PRECISION SPEEDTAC®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MBI·July 18, 2014
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017