8 results
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18ms
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Sources: EU EUDAMED, US FDA
ELITE ELECTROCARDIOGRAPH
FDA 510(k)THORACIC DRAINAGE SET, ARGYLE DUAL
FDA 510(k)
FDA Class 2
·General Hospital
FUJI IP CASSETTE TYPE PC
FDA 510(k)
FDA Class 2
·Radiology
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 12, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 15, 2010
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 12, 2012
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
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