7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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W&H MICRO AIR MOTOR LT25
FDA 510(k)
FDA Class 1
·Dental
UNIVERSAL SURGICAL INSTRUMENT HOLDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PCA MODULAR PRIMARY/REVISION PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 5, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 3, 2011
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 18, 2014
PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 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