9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LightStim for Pain LED Belt
FDA 510(k)
FDA Class 2
·Physical Medicine
CRYOCARE CS SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NITRILE EXAMINATION GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
FDA Adverse Event
Injury
·ZEST ANCHORS, LLC·Product code DZE·December 23, 2015
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 58MM FOR IM NAILS
FDA Adverse Event
Injury
·SYNTHES·Product code HWC·June 7, 2013
PRESSURE SENTINEL FLEXIBLE REAMER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HWE·June 21, 2011
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
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014