11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA ZYME PLUS LDH #64950, 65038 & 39
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARx SAI
FDA UDI
Life Spine, Inc.·00190837190651·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837173715·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837189181·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837173111·
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
FDA 510(k)
FDA Class 2
·Radiology
NOVOSYN UNDYED 3/0 (2) 70CM DS24 (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAM·April 17, 2014
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
GREENLINE FIBER OPTIC "D" MACINTOSH #4 BLADE
FDA Adverse Event
Injury
·MEDICAL DEVICES (PVT) LTD·Product code CAL·August 16, 2010
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