7 results
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17ms
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Sources: EU EUDAMED, US FDA
MODEL 5151
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROINFERTILITY NEEDLE HOLDER, TITANIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ELIACHAR MODIFIED ESOPHAGEAL STENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 5, 2013
PULSEWAVE SNGL SPIKE NO PROBE
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code GBX·January 3, 2011
XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 18, 2014
PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 29CM, P/N 0250282047 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