19 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
Parallel Bypass, TCA Tosoh G8
FDA UDI
Thermo Fisher Scientific Oy·06438153003359·Parallel Bypass, TCA Tosoh G8 is a module of TC...
CLIRPATH TURBO EXCIMER LASER CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
OncoPatch
FDA 510(k)
FDA Class 2
·Radiology
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·June 30, 2014
ENRHYTHM MRI
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·February 9, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 7, 2011
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
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