7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LMI ARTERIAL EMBOLECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CHURCHHILL LANCET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSYNC III PROTECT
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·February 11, 2013
CURRENT RF VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011
TVC INSIGHT CATHETER
FDA Adverse Event
Injury
·INFRAREDX INC.·Product code OGZ·July 18, 2014
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 30, 2022