10 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ASSERA-PLATE PROTEIN C KIT
FDA 510(k)
FDA Class 2
·Hematology
APPLICATION OF EMIT AED ASSAYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASTROTILT MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
REFLEXION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code DRF·May 21, 2014
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 8, 2010
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC..·Product code LZG·November 28, 2012
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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