7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Invictus Robotic Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
SR ADORO
FDA 510(k)
FDA Class 2
·Dental
YEESCOPE LARYNGOSCOPES
FDA 510(k)
FDA Class 1
·Anesthesiology
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 5, 2014
MINSTREL
FDA Adverse Event
Malfunction
·MEDIBO MEDICAL PRODUCTS NV·Product code FSA·September 6, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 22, 2013
PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014