7 results
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18ms
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Sources: EU EUDAMED, US FDA
MEDSURG CHIBA PTC NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Materialise Glenoid Positioning System
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2014
ULTAMET MTL INS NEUT 36MM 62OD
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWA·October 7, 2010
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·December 12, 2012
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