7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EasyCare Tx 2
FDA 510(k)
FDA Class 2
·Anesthesiology
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET
FDA 510(k)
FDA Class 2
·Anesthesiology
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JDL·November 10, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013
PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. 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