7 results
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18ms
·
Sources: EU EUDAMED, US FDA
WATERS(TM) LC MODULE I FOR CLINICAL USE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STARTOX DRUG OF ABUSE SCREENING TEST (4)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
FDA 510(k)
FDA Class 2
·Cardiovascular
LEAVE ACTIVE PFC PLI 10MM SZ2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 18, 2013
RELIA SR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NVZ·December 13, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 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