10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DEKNATEL THORACIC CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
Beyes
FDA UDI
Beyes Dental Canada Inc·00990010306592·FG 12 BLADE FINISHING CARBIDE 7204
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024197664·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024197671·
COLLAGEN BONE HEALING PROTECTIVE SHEET
FDA 510(k)
FDA Class 2
·Orthopedic
Renaissance X System
FDA 510(k)
FDA Class 2
·Neurology
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·June 5, 2014
ENDOTAK DSP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 4, 2010
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 30, 2012
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024