7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ INSULATED SCISSORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SUPPLEMENTAL FEEDING SYSTEM
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ST-4 COAGULATION INSTRUMENT
FDA 510(k)
FDA Class 2
·Hematology
ANGEL WING 21G BCS W/LUER ADPTR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMI·May 8, 2014
VENACURE NEVERTOUCH
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code GEX·January 11, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·December 6, 2010
PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. 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