10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
FDA 510(k)
FDA Class 2
·Hematology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981342·anteriors; shade C4; mould IM4
REPROCESSED EXTERNAL FIXATION ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
JGH1 Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020
PULSE GENERATOR 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 27, 2013
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·February 2, 2011
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·August 5, 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