9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ELPHA 4 CONTI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VITAL COUGH
FDA 510(k)
FDA Class 2
·Anesthesiology
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
SCULPTRA
FDA Adverse Event
Injury
·SANOFIAVENTIS U.S. LLC·Product code LMH·December 15, 2010
GALILEO NEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·July 14, 2014
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·December 31, 2012
INFUSOMAT SPACE PUMP IV SET
FDA Adverse Event
Malfunction
·B. BRAUN DOMINICAN REPUBLIC·Product code FPA·November 17, 2009
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