8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
CRISS-CROSS VEST RESTRAINT
FDA 510(k)
FDA Class 1
·General Hospital
Galvanic Spa, Model: SKB-1405
FDA 510(k)
FDA Class 2
·Neurology
AYCAN WORKSTATION OSIRIX
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KGE·April 4, 2017
HEARTSTART FR3 TEXT, BASIC BUNDLE, JAPAN
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 21, 2014
PERIGEE SYSTEM WITH INTEPRO
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·February 13, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·January 10, 2011
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020