9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROTON BEAM THERAPY SYSTEM (PBTS)
FDA 510(k)
FDA Class 2
·Radiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198697·AK3 Ultra Insert Trial Size 4, 14mm
Arthrex®
FDA UDI
ARTHREX, INC.·00888867401037·2.4mm Snap-off FT Pin 14mm
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
FDA 510(k)
FDA Class 2
·General Hospital
Praxiject 0.9% NaCl
FDA 510(k)
FDA Class 2
·General Hospital
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 7, 2013
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
ENPULSE DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 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