7 results · 26ms · Sources: EU EUDAMED, US FDA

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PAIN DOC

FDA 510(k)
FDA Class 2 ·Neurology

IMPRUV A.I. CREAM WOUND AND SKIN EMULSION

FDA 510(k)
FDA Unclassified ·Unknown

WEARABLE THERAPY GARMENTS

FDA 510(k)
FDA Class 2 ·Neurology

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·February 4, 2013

PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 29, 2010

DELTAMAXX - PLATINUM MICROCOIL

FDA Adverse Event
Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·July 17, 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