8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CONMED VCARE RETRACTOR/ELEVATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118093950·SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM...
MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
STRETCH WRAP
FDA 510(k)
FDA Class 1
·General Hospital
SYMBIQ DCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 12, 2014
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·February 11, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 10, 2011
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