7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
FDA 510(k)
FDA Class 2
·Anesthesiology
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
FDA 510(k)
FDA Class 2
·Neurology
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
FDA 510(k)
FDA Class 2
·Orthopedic
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·November 10, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 9, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2013
PKG, BABCOCK FORCEPS, P/N 0250080321. 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