10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AES STOCKINGS
FDA 510(k)
FDA Class 2
·General Hospital
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788224460·Cervical Trial +DS 7x14x12 Lordotic
LIQUIDBAND FLOW CONTROL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023
ON-Q C-BLOCK W/DUALSAF 400ML, 1-7ML/HR+1-7ML/HR
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·November 2, 2012
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 20, 2014
PERIFIX
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC·Product code CAZ·August 11, 2010
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