7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iBOT® PMD
FDA 510(k)
FDA Class 2
·Physical Medicine
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
FDA 510(k)
FDA Class 2
·Neurology
Inbrace Orthodontic System
FDA 510(k)
FDA Class 2
·Dental
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
DLP SINGLE STAGE VENOUS CANNULA
FDA Adverse Event
Malfunction
·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·August 19, 2011
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·July 23, 2013
PKG, 5MM ROTATING HANDLE, INSULATED SHAFT/ HANDLE 45CM LENGTH, P/N 0250080595 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