7 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
FDA 510(k)
FDA Class 2
·Orthopedic
Polysmith Sleep System
FDA 510(k)
FDA Class 2
·Neurology
TRANSPORT SERIES
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·December 10, 2010
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·February 4, 2013
WIRE,SURGICAL
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code LRN·July 17, 2014
PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. 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