8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRANSVAGINAL PROBE, MODEL ED65M-TV
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
P.F.C.
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295216209·P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 1.5 10 DEG
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonoma Fifth Metatarsal Repair System
FDA 510(k)
FDA Class 2
·Orthopedic
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·December 7, 2012
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 22, 2015
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