10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TIBC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981279·anteriors; shade C2; mould BS2
Symmetry
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482087589·Symmetry® Forceps, Paddle Babcock, Ratcheting H...
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
FDA 510(k)
FDA Class 2
·Neurology
Ysio Max
FDA 510(k)
FDA Class 2
·Radiology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 27, 2013
STERLING? SL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·August 5, 2014
LIMA HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JDI·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