9 results
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18ms
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Sources: EU EUDAMED, US FDA
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981272·anteriors; shade C2; mould CM4
Symmetry
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482087480·Symmetry® Forceps, Claw, Standard Handle w/Rota...
Picocare Family
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORCINE SURGICAL MESH; DERMAL MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·February 27, 2013
OBTAPE TRANSOBURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code OTN·July 24, 2014
HENRY SCHEIN NATURAL ELEGANCE FLOWABLE
FDA Adverse Event
Other
·SEPTODONT CONFI-DENTAL DIVISION·Product code EBF·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