7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VIDEO OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
IMPLANET Spine System (ISS)
FDA 510(k)
FDA Class 2
·Orthopedic
HEXIM Implant; Samwon General Abutments
FDA 510(k)
FDA Class 2
·Dental
DISPOSABLE MINI ENDOCUT SCISSORS TIP
FDA Adverse Event
Other
·MICROLINE SURGICAL INN·Product code KNS·December 16, 2010
BARD FLAT MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 29, 2013
ADVIA CENTAUR XP FOLATE (FOL) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CGN·July 18, 2014
PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 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