12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WELCH ALLYN OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Liberant Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Universal Spike
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NLM·June 9, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 8, 2013
CONFIENT
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
iPico Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code NFO·January 6, 2012
Perfector Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012
Ion Magnum Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012
IELLIOS Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code NFO·January 6, 2012
Arasys Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024