9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 13, 2012
Zeta Navigation System
FDA 510(k)
FDA Class 2
·Neurology
Vario 8/18/ci
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONCERTO CRT-D DR AT
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·February 9, 2013
ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·July 23, 2014
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·January 10, 2011
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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