7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE INSTRUMENT TRAYS-VARIOUS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPECTRON PROXIMAL FEMORAL PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TOTALCARE BARIATRIC BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 12, 2014
*
FDA Adverse Event
Malfunction
·CAREFUSION·Product code LSZ·October 29, 2012
TOTALCARE-TREAT SURFACE & SCALE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·September 21, 2010
PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM, P/N 0250282100 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