8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
FDA 510(k)
FDA Class 2
·General Hospital
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665586902·MIS Cannulated Screw M, Ø10.5 x 55mm, Ø5.5mm Rod
JOURNEY II BCS CONSTRAINED INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
IMPAX CLIENT EMBRACE
FDA 510(k)
FDA Class 2
·Radiology
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 18, 2014
PERIGEE SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 30, 2013
NEXGEN LPS-FLEX POLY ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·December 21, 2010
PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 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