12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
FDA 510(k)
FDA Class 2
·Microbiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704286175·
LEVEL ONE ORTHOANCHOR
FDA UDI
KLS-Martin L.P.·00888118093868·PLATE, DBL HOOK, STELNICKI/MARCHETTO, LEFT, 18 ...
LEVEL ONE ORTHOANCHOR
FDA UDI
KLS-Martin L.P.·00888118093899·PLATE, DBL HOOK, STELNICKI/MARCHETTO, RIGHT, 8 ...
LEVEL ONE ORTHOANCHOR
FDA UDI
KLS-Martin L.P.·00888118093875·PLATE, DBL HOOK, STELNICKI/MARCHETTO, RIGHT, 18...
LEVEL ONE ORTHOANCHOR
FDA UDI
KLS-Martin L.P.·00888118093882·PLATE, DBL HOOK, STELNICKI/MARCHETTO, LEFT, 8 M...
K-WIRE
FDA 510(k)
FDA Class 2
·Orthopedic
STAT K SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INSYNC MAXIMO
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 11, 2013
PRECISION XCEED PRO
FDA Adverse Event
Malfunction
·Product code NBW·January 10, 2011
SMALL GRASPING RETRACTOR INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 24, 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