9 results
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28ms
·
Sources: EU EUDAMED, US FDA
HOFMANN-NAGEL (HOFNA) X-RAY TUBES
FDA 510(k)
FDA Class 1
·Radiology
AQUALOC®
FDA UDI
Biomet Orthopedics, LLC·08428898892712·
SECURMIX
FDA 510(k)
FDA Class 2
·General Hospital
SE-601 SERIES ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
ARCHITECT C4000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·July 31, 2018
COR14000287-000
FDA Adverse Event
Other
·Product code RDA·June 27, 2014
ADAPTER SLEEVE 11/13 +3
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 7, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·October 26, 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