10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
FDA 510(k)
FDA Class 2
·Orthopedic
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551077740·Seeker, 45°, 15.5 cm
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·00699753507678·
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
FDA 510(k)
FDA Class 3
·Cardiovascular
IDENTITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 18, 2011
VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DWF·July 10, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026