10 results
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26ms
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Sources: EU EUDAMED, US FDA
SAS SALMONELLA H A ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221118110·3M™ Victory Series™ Second Molar Bands, 955-216...
Zuma™
FDA UDI
Seaspine Orthopedics Corporation·10889981037666·Trial, 32mm x 25mm x 16mm, 8 Deg. Zuma™ Trials ...
SOLUTION SYSTEM CUP
FDA 510(k)
FDA Class 2
·Orthopedic
3M ARTHROSCOPIC SURGICAL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 11, 2013
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·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