7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Z0174, IMPEDANCE AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CK-B RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
FDA 510(k)
FDA Class 2
·Immunology
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014
LCS COMPLETE FEM CEM L LG
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code NJL·November 26, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·September 27, 2010
PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. 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