8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
FDA 510(k)
FDA Class 2
·Orthopedic
StimOnTM Pain Relief System (GM2439)
FDA 510(k)
FDA Class 2
·Neurology
X-Pac Expandable Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 29, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 24, 2008
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 23, 2013
PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. 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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025