7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PROTEX CONTRACEPT PLUS W/SPERM-LUB
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
DVNET MDV-PACS
FDA 510(k)
FDA Class 2
·Radiology
SORIN CONNECT DATA MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A·Product code HTO·March 6, 2014
REPLY
FDA Adverse Event
Injury
·SORIN CRM S.R.L.·Product code NVZ·November 9, 2012
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 8, 2010