7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CARBAMAZEPINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EXEL BUTTERFLY SCALP VEIN SET
FDA 510(k)
FDA Class 2
·General Hospital
BONETRAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·May 20, 2014
OSS POLY FEMORAL BUSHINGS 2/PK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·November 6, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 4, 2015
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024