9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI
FDA 510(k)XANAR MODEL XSE-300 SMOKE EVACULATER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL XLE
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN SCREW
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code HWC·June 19, 2014
OCTRODE 8 PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC·Product code LGW·October 21, 2010
5MM MONOPOLAR CAUTERY INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 21, 2012
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·November 4, 2020
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·November 4, 2020
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