7 results
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17ms
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Sources: EU EUDAMED, US FDA
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DORNIER MEDILAS H LASER FIBER CABLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TERUMO SURFLASH SAFETY I.V. CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
TECNIS 1-PIECE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·July 17, 2015
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014
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