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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AMERLITE TBG ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221115683·3M™ Victory Series™ First Molar Bands, 952-284,...
REFORMAT GATEWAY
FDA 510(k)
FDA Class 2
·Radiology
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 13, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
CONTAK RENEWAL TR
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NKE·January 7, 2011
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
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