11 results
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17ms
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Sources: EU EUDAMED, US FDA
UREA NITROGEN REAGENT SET (MOD. BERTHEL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788222370·Cervical Rasp 11x12x12
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18222371·
BIOPHOTAS LIFELIGHT
FDA 510(k)
FDA Class 2
·Physical Medicine
Cala kIQ
FDA 510(k)
FDA Class 2
·Neurology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER- STRAIGHT 60 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·December 3, 2007
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·November 7, 2012
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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