8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dilapan-S
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RISE SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VIPER¿ LT SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 6, 2014
DRILLSL 11/3.2 L222 F/357.369
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·June 3, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 29, 2011
PKG, FUNDUS FORCEPS, P/N 0250080315. 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