7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MASTERSON* ENDOMETRIAL BIOPSY KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OMNI TiN Coated Apex Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 6, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 15, 2012
KRH BUSHING STANDARD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·August 4, 2010
Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016