8 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 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
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 24, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 21, 2012
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code DTB·July 3, 2014
PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. 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