12 results
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20ms
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Sources: EU EUDAMED, US FDA
Habib EUS RFA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638397·CoRoent Ant TLIF PEEK, 16x11x30mm 15°
Life Instruments
FDA UDI
Life Instrument Corporation·M930716130520·Coutts Scoop #5 Left
Cervical Interbody 13mm x 12mm x 5mm
FDA UDI
XENCO MEDICAL LLC·B064XM21613051·
Life Instruments
FDA UDI
Life Instrument Corporation·M930716130510·Coutts Scoop #5 Right
BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
FDA Adverse Event
Malfunction
·LEE LABORATORIES, INC.·Product code MDB·March 3, 2023
MEDICAL DISPLAY, MDC1900-1LG (1LR)
FDA 510(k)
FDA Class 2
·Radiology
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 11, 2013
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·July 13, 2011
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MAF·September 11, 2008
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.
FDA Enforcement
Class III
·Terminated·ELITech Group B.V.·October 9, 2019