7 results
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25ms
·
Sources: EU EUDAMED, US FDA
VITALOG PMS-8
FDA 510(k)
FDA Class 2
·Cardiovascular
COAT-A-COUNT ESTRADIOL KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MOBILIZER
FDA 510(k)
FDA Class 1
·Physical Medicine
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·November 26, 2012
PUMP MMT-522WWB PRDGM INSULIN BL EN US
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·September 13, 2010
PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. 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