8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER
FDA 510(k)
FDA Class 2
·Physical Medicine
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641035·OPAQUE MATERNITY 20-30 MM HG KNEE HIGH ZIG ZAG ...
PS SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LensGiene Sterile Saline Solution
FDA 510(k)
FDA Class 2
·Ophthalmic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·November 29, 2012
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