12 results
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26ms
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Sources: EU EUDAMED, US FDA
CORNING 101 PRINTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788221460·Tranquil – L Tray 2
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268221460·
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR28221461·Betaflex wires Titanium Straight-Arch-F. mand. ...
XHIBIT CENTRAL STATION, MODEL 96102
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·May 20, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 7, 2012
CONSERVE(R) PLUS SPIKED CUP
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KWA·June 5, 2015
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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