9 results
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17ms
·
Sources: EU EUDAMED, US FDA
EASY-ON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VQ ORTHOCARE
FDA UDI
Vision Quest Industries Incorporated·00817717022429·OACTIVE ALIGN CUSTOM PB HD R
VQ ORTHOCARE
FDA UDI
Vision Quest Industries Incorporated·00817717022412·OACTIVE ALIGN CUSTOM PB R
WANDY SELF-ADHESIVE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
Montage- XT Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
TROCHANTERIC NAIL KIT, TI 11X200MM X120
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 10, 2010
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 14, 2014
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·December 31, 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