8 results
·
41ms
·
Sources: EU EUDAMED, US FDA
SIENET TELERADIOLOGY PRODUCT LINE
FDA 510(k)
FDA Class 2
·Radiology
MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·February 11, 2013
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 10, 2011
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·December 13, 2013
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024