10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HEMATOXYLIN STAIN
FDA 510(k)
FDA Class 1
·Hematology
Masel
FDA UDI
Ortho Organizers, Inc.·00190707034177·.020 Upper Stainless Steel Golden International...
C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
FDA 510(k)
FDA Class 2
·Ophthalmic
ENSITE CLASSIC SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DQK·February 9, 2010
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 28, 2014
ACCOLADE PLUS TMZF HIP STEM#5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·October 17, 2012
I-STAT ACT KAOLIN CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE CANADA LTD.·Product code JBP·August 26, 2010
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012