9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690113966·PS-R Insert, Size 2 x 12mm
HIGH-PRESSURE CONNECTOR TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
BARD SINGULAR BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
THORACIC PEDICLE PROBE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HXX·February 9, 2015
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 7, 2010
TENDRIL DX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013