Burke Inc

FDA Filings

This page includes the latest FDA filings for Burke Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1919278
FEI Number1919278
NameBURKE, INC.
Owner & OperatorBURKE, INC.
Contact Address1800 MERRIAM LN. --
Kansas City KS 66106 US
Official Correspondent
  • DUWAYNE E KRAMER
  • x-800-2554147-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1800 MERRIAM LN.
KANSAS CITY, KS 66106 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
BURKE, INC.
Scout 831812018-07-06
BURKE, INC.
Scout 831802018-07-06
BURKE, INC.
Scout 831732018-07-06
BURKE, INC.
Scout 826772018-07-06
BURKE, INC.
Scout 826762018-07-06
BURKE, INC.
Scout 826282018-07-06
BURKE, INC.
PS Scout 825652018-07-06
BURKE, INC.
Scout 825542018-07-06
BURKE, INC.
Scout 824912018-07-06
BURKE, INC.
Scout 823892018-07-06
BURKE, INC.
Scout 823482018-07-06
BURKE, INC.
Scout 823382018-07-06
BURKE, INC.
Scout 820622018-07-06
BURKE, INC.
Scout 81855A2018-07-06
BURKE, INC.
Scout 81445A2018-07-06
BURKE, INC.
Scout 811222018-07-06
BURKE, INC.
Scout 81113A2018-07-06
BURKE, INC.
PaceSaver 174782018-07-06
BURKE, INC.
Pacesaver 174772018-07-06
BURKE, INC.
Pacesave 150902018-07-06
BURKE, INC.
Pacesaver 150872018-07-06
BURKE, INC.
PaceSaver 150862018-07-06
BURKE, INC.
Pacesaver 150852018-07-06
BURKE, INC.
Pacesaver 150832018-07-06
BURKE, INC.
Pacesaver 150732018-07-06
BURKE, INC.
Pacesaver 150722018-07-06
BURKE, INC.
Pacesaver 150702018-07-06
BURKE, INC.
Pacesaver 150682018-07-06
BURKE, INC.
Pacesaver 150672018-07-06
BURKE, INC.
Pacesaver 150632018-07-06
BURKE, INC.
Pacesaver 150572018-07-06
BURKE, INC.
Pacesaver 150352018-07-06
BURKE, INC.
Scout 822502018-07-06
BURKE, INC.
Scout 831822018-03-29
BURKE, INC.
Scout 826472018-03-29
BURKE, INC.
Scout 823062018-03-29
BURKE, INC.
Burke 634102018-03-29
BURKE, INC.
Burke 63398B2018-03-29
BURKE, INC.
Burke Inc 633902018-03-29
BURKE, INC.
Burke 631872018-03-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Tri-Flex II PM2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Lisure-Lift2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Leisure-Lift Scout Stanza2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Leisure-lift2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Leisure-Lift2013-01-29
BURKE, INC.
Tri-FlexII NC2013-01-29
BURKE, INC.
Tri-Flex II Acc 10002013-01-29
BURKE, INC.
Barri-Float mattress 54"2010-08-23
BURKE, INC.
Barri-Float mattress 48"2010-08-23
BURKE, INC.
Tri-Flex II Air2010-08-17
BURKE, INC.
PaceSaver Scout TPB2007-11-16
BURKE, INC.
PaceSaver Scout RF-SP2007-11-16
BURKE, INC.
PaceSaver Scout RF-P4 TPB-S2007-11-16
BURKE, INC.
PaceSaver Scout RF-P4 TPB-N2007-11-16
BURKE, INC.
PaceSaver Scout RF TPB2007-11-16
BURKE, INC.
PaceSaver Scout RF 4-P2007-11-16
BURKE, INC.
Pace Saver Scout RF2007-11-16
BURKE, INC.
Pace Saver Scout RF42007-11-16
BURKE, INC.
Pace Saver Scout RF-P42007-11-16
BURKE, INC.
Pace Saver Scout RF-P4 W/S2007-11-16
BURKE, INC.
Pace Saver Scout M12007-11-16
BURKE, INC.
Pace Saver Scout M1 TPB2007-11-16
BURKE, INC.
Pace Saver Scout M1 3502007-11-16
BURKE, INC.
Pace Saver Scout Equalizer2007-11-16
BURKE, INC.
Pace Saver Scout 4P2007-11-16
BURKE, INC.
PaceSaver Espree Titan2007-11-16
BURKE, INC.
PaceSaver Espree Premier2007-11-16
BURKE, INC.
PaceSaver Espree Atlas2007-11-16
BURKE, INC.
PaceSaver Espree Atlas52007-11-16
BURKE, INC.
PaceSaver Plus III Titan2007-11-16
BURKE, INC.
PaceSaver Plus III Premier2007-11-16
BURKE, INC.
PaceSaver Plus III Jr2007-11-16
BURKE, INC.
PaceSaver Plus III Atlas2007-11-16
BURKE, INC.
PaceSaver Eclips Premier2007-11-16
BURKE, INC.
PaceSaver Eclips Atlas2007-11-16
BURKE, INC.
PaceSaver Eclips Atlas 52007-11-16
BURKE, INC.
PaceSaver Little Jr2007-11-16
BURKE, INC.
PaceSaver Fusion 5002007-11-16
BURKE, INC.
PaceSaver Fusion 4502007-11-16
BURKE, INC.
PaceSaver Fusion 3502007-11-16
BURKE, INC.
PaceSaver Fusion 2502007-11-16
BURKE, INC.
PaceSaver Scout Boss Equalizer2007-11-16
BURKE, INC.
PaceSaver Scout Boss 62007-11-16
BURKE, INC.
PaceSaver Scout Boss 6.752007-11-16
BURKE, INC.
PaceSaver Scout Boss 6.75 TPB2007-11-16
BURKE, INC.
PaceSaver Scout Boss 6 TPB2007-11-16
BURKE, INC.
PaceSaver Scout Boss 6 NS2007-11-16
BURKE, INC.
PaceSaver Scout Boss 6 NS TPB2007-11-16
BURKE, INC.
PaceSaver Scout Boss 4.5 TPB2007-11-16
BURKE, INC.
PaceSaver Scout Boss 4.5 NS2007-11-16
BURKE, INC.
FUSION2006-08-01
BURKE, INC.
SCOUT BOSS2002-12-24
BURKE, INC.
SCOUT1998-08-31
BURKE, INC.
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)1997-07-17
BURKE, INC.
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM1991-07-19
BURKE, INC.
COLD/HOT FLUID RADIATION PAD NEUTECH1989-06-22
BURKE, INC.
PACESAVER & SCOUT1984-01-30
BURKE, INC.
Tri-Flex II1977-12-20

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020020652533Taipei,China (Taiwan) -> Los Angeles, CaliforniaWHEELCHAIR PARTS TUBE/LEG,ALUM,FOOTPLATE HS CODE:8714.2028 CTN

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