8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIR ENTRAINER 900RT008
FDA 510(k)
FDA Class 2
·Anesthesiology
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575194636·Replacement set, TiNbN coating, CoCrMo, UHMWPE,...
RHEOLOGIC I
FDA 510(k)
FDA Class 2
·Physical Medicine
5.0 MHZ INTRACAVITARY SECTOR PROBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·February 9, 2013
DEPUY PINNACLE SECTOR II ACETABULAR CUP 54MM W METAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code KWA·January 4, 2011
UNKNOWN, HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 23, 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