9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DAR-2400-15B/30B
FDA 510(k)
FDA Class 2
·Radiology
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
FDA 510(k)
FDA Class 2
·Radiology
TECHNOMED PULSOLITH 4000 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIRTUOSO DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·February 11, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 10, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 24, 2014
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
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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