8 results
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19ms
·
Sources: EU EUDAMED, US FDA
NON CORING INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
FDA 510(k)
FDA Class 2
·General Hospital
CATHODE RAY TUBE MED. DISPLAY
FDA 510(k)
FDA Class 2
·Cardiovascular
SPEEDBAND SUPERVIEW SUPER 7?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FHN·June 18, 2014
FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS, HEARTSTREAM·Product code MKJ·October 6, 2010
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·December 20, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013