9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMG OPTION FOR MICROSHEV 4000
FDA 510(k)
FDA Class 2
·Neurology
N/A
FDA UDI
STRYKER CORPORATION·07613327657838·Attachment Insert Tray - Bottom
BACT/ALERT MB CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
CHROMOPHARE E 668
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·November 23, 2020
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·June 27, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 7, 2013
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION·Product code IZL·October 26, 2010
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