7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AxCess® Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code FRN·January 28, 2013
OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code MBI·December 17, 2010
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 18, 2014
PKG, 5MM INSERT, TENACULUM, 33CM, P/N 0250080698 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