10 results
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29ms
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Sources: EU EUDAMED, US FDA
INTRODUCER NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902304224·HEAD 8910641 REMOVAL T8
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756366199·D&C GYN PACK
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GE CT-PET SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 4, 2012
MULTI-LUMEN CVC KIT: 4-L 8.5 FR X 16 CM
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code FOZ·November 19, 2010
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·July 2, 2014
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·September 25, 2013
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code HXX·August 12, 2013