9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PYR DISCS
FDA 510(k)
FDA Class 1
·Microbiology
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148603020·
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GONIOMETER, INTER. STAND. LARGE, BK7514
FDA 510(k)
FDA Class 1
·Orthopedic
TIBIAL PLATE FB SZ 1 LT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·January 31, 2024
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LMH·November 15, 2012
HEARTMATE APICAL CORING KNIFE
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code EMF·September 22, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012