9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UPRO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981295·anteriors; shade C2; mould UM6
LAMINARIA CUREX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Genesys Spine AIS-C Cervical Stand-Alone System
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 20, 2014
PENUMBRA RUBY COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code KRD·February 27, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 2, 2011
L.C. 5000/CE 2-CHANNEL PUMP (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·August 22, 2013
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