8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NITRILON CORRECT-TOUCH
FDA 510(k)
FDA Class 1
·General Hospital
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981333·anteriors; shade C4; mould BS2
ADVIA Centaur Herpes-1 IgG
FDA 510(k)
FDA Class 2
·Microbiology
CENTRAL CATHETER TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MGB·February 27, 2013
TRI TS BASEPLATE SIZE 3
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·August 5, 2014
RUSCH 100% SILICONE 3WAY FOLEY
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FCM·February 2, 2011
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