7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SARNS AIR DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PARAMED FLEXION-EXTENSION MACHINE
FDA 510(k)
FDA Class 1
·Physical Medicine
UNK
FDA Adverse Event
Injury
·Product code HWC·February 1, 2013
0.8% SURGISCREEN
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·January 4, 2011
7.0MM TI SIDE-OPENING SCREW 60MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·July 21, 2014
PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. 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