8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGI-LINK ELECTROSURGICAL ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Damon 3MX
FDA UDI
ORMCO CORPORATION·00889989002348·L3L DAMON3 MX 22 7/5/0
DUAL LUMEN NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXPRESS® LD ILIAC / BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIO·February 5, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC.·Product code MIH·December 28, 2010
DELTA V-40 CERAMIC HEAD 32/0
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·July 18, 2014
PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 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