20 results · 25ms · Sources: EU EUDAMED, US FDA

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NEURONET

FDA 510(k)
FDA Class 2 ·Neurology

SHOULDER NAIL PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

FDR Visionary Suite

FDA 510(k)
FDA Class 2 ·Radiology

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 13, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·February 9, 2013

COGNIS

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·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

SELDRILL-SCHANZSCR Ø5 L200/80 SST

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

STEALTH 32 LHOOK LAP ELEC PKG

FDA Adverse Event
Malfunction ·CONMED UTICA·Product code GEI·November 12, 2021

STEALTH 32 LHOOK LAP ELEC PKG

FDA Adverse Event
Malfunction ·CONMED UTICA·Product code GEI·November 12, 2021

SELDRILL-SCHANZSCR Ø5 L200/80 SST

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

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