13 results
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19ms
·
Sources: EU EUDAMED, US FDA
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
Armada
FDA UDI
Nuvasive, Inc.·00887517391483·ARM15S Screw, 4.5x25mm Fixed
ReLine
FDA UDI
Nuvasive, Inc.·00195377074867·RELINE C Screw, 4.5x25mm Cort Canc
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665587961·MIS Fenestrated Screw M, Ø4.5 x 25mm, Ø5.5mm Rod
FOX FASTIDIOUS TEST PANEL
FDA 510(k)
FDA Class 2
·Microbiology
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 11, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·January 10, 2011
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·July 17, 2014
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020