8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
FDA 510(k)
FDA Class 2
·Neurology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551082430·Hook, 90°, blunt, 4 mm, 17.5 cm
Trigon HA Stand-Alone Wedge Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ANGIOVAC CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
CHECK-FLO INTRODUCER SET
FDA Adverse Event
Malfunction
·COOK MEDICAL·Product code DYB·October 26, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
MNS UNKNOWN CATHETER
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·July 18, 2013
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·June 24, 2015