8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Aevumed RAPID Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
IDENTITY ADX XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 18, 2011
CLINITRON RITEHITE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INX·July 2, 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