Cardiac Science Corp

FDA Filings

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

Cardiac Science Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• CHARLES MACK
• Cardiac Science

FDA Registration(s)

• Registration Number: 3007093951
• FEI Number: 3007093951
• Name: Paul Dias
• Owner & Operator: CARDIAC SCIENCE CORPORATION
• Contact Address: 500 Burdick Parkway --; Deerfield WI 53531 US
• US Agent:
  • Paul Dias
  • ZOLL Medical Corporation
  • 978 4219413
  • pdias@zoll.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 269 Mill Road ; Chelmsford, MA 01824 US
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 3012851662
• FEI Number: 3012851662
• Name: Cardiac Science
• Owner & Operator: CARDIAC SCIENCE CORPORATION
• Contact Address: 500 Burdick Parkway --; Deerfield WI 53531 US
• US Agent:
  • Jaime Lewellin
  • Cardiac Science Corporation
  • 608 7647040
  • jlewellin@zoll.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Unit 2 Rugby Park Battersea Road, Heaton Mersey; Stockport Stockport, SK4 3EB GB
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 0
• FEI Number: 0
• Name: Cardiac Science SRL
• Owner & Operator: CARDIAC SCIENCE CORPORATION
• Contact Address: 500 Burdick Parkway --; Deerfield WI 53531 US
• US Agent:
  • Paul Dias
  • ZOLL Medical Corporation
  • 978 4219413
  • pdias@zoll.com
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Via Francesco Corselli 11 ; Piacenza Piacenza, I-29122 IT
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 2112020
• FEI Number: 2112020
• Name: CARDIAC SCIENCE CORPORATION
• Owner & Operator: CARDIAC SCIENCE CORPORATION
• Contact Address: 500 Burdick Parkway --; Deerfield WI 53531 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 500 Burdick Pkwy ; DEERFIELD, WI 53531 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00847946046170 CARDIAC SCIENCE CORPORATION	Sunmed	2021-11-01
GUDID 00847946046163 CARDIAC SCIENCE CORPORATION	Sunmed	2021-11-01
GUDID 00847946046156 CARDIAC SCIENCE CORPORATION	Sunmed	2021-11-01
GUDID 00847946046132 CARDIAC SCIENCE CORPORATION	Sunmed	2021-11-01
GUDID 00847946046125 CARDIAC SCIENCE CORPORATION	SunMed	2021-11-01
GUDID 00847946046118 CARDIAC SCIENCE CORPORATION	Sunmed	2021-11-01
GUDID 00847946046200 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Electrodes	2021-08-26
GUDID 00847946046194 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Electrodes	2021-08-26
GUDID 00847946046187 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Electrodes	2021-08-26
GUDID 00812394023301 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Automatic AED 9390A-1001-TSO	2020-12-10
GUDID 00812394023349 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Semi Automatic 9390E-1001-TSO	2020-12-09
GUDID 00812394023332 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Semi Automatic Stocking Package 9390E-1001SP	2020-12-09
GUDID 00812394023325 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Semi Automatic 9390E-1001	2020-12-09
GUDID 00812394023318 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Semi-Automatic AED 9390E-01	2020-12-09
GUDID 00812394023295 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Automatic AED, stocking package 9390A-1001SP	2020-12-09
GUDID 00812394023288 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Automatic AED 9390A-1001	2020-12-09
GUDID 00812394023271 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Automatic AED 9390A-01	2020-12-09
GUDID 00812394023257 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Pro AED, Stocking Package 9300P-1001SP	2020-12-09
GUDID 00812394023240 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Pro AED 9300P-1001	2020-12-09
GUDID 00812394023233 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Pro 9300P-01	2020-12-09
GUDID 00812394023219 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Semi Automatic AED 9300E-1001-TSO	2020-12-09
GUDID 00812394023202 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Semi-Automatic AED 9300E-01	2020-12-09
GUDID 00812394023189 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Automatic AED 9300A-1001-TSO	2020-12-09
GUDID 00812394023172 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Automatic AED 9300A-01	2020-12-09
GUDID 00812394023165 CARDIAC SCIENCE CORPORATION	Powerheart® G3 Elite Semi-Automatic AED 9790E-19	2020-07-09
GUDID 00812394023158 CARDIAC SCIENCE CORPORATION	Powerheart® G3 Elite Automatic AED 9790A-19	2020-07-09
GUDID 00812394023141 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Semi Automatic AED G5S-19P0	2020-07-09
GUDID 00812394023134 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Automatic AED G5A-19P0	2020-07-09
GUDID 00812394023127 CARDIAC SCIENCE CORPORATION	Powerheart® G3 Elite Semi-Automatic AED Kit 9790E-1019	2020-07-09
GUDID 00812394023110 CARDIAC SCIENCE CORPORATION	Powerheart G3 Elite Automatic AED Kit 9790A-1019	2020-07-09
GUDID 00812394023103 CARDIAC SCIENCE CORPORATION	Powerheart G5 Automatic AED G5A-19C	2020-07-09
GUDID 00812394023097 CARDIAC SCIENCE CORPORATION	Powerheart G5 Semi Automatic AED G5S-19C	2020-07-09
GUDID 00812394022779 CARDIAC SCIENCE CORPORATION	Powerheart G5 Semi Automatic AED G5S-19A	2020-07-09
GUDID 00812394022243 CARDIAC SCIENCE CORPORATION	Powerheart G5 Automatic AED G5A-19A	2020-07-09
MKJ Paul Dias [CARDIAC SCIENCE CORPORATION]	Powerheart G3 Elite AED	2020-02-07
MKJ Cardiac Science SRL [CARDIAC SCIENCE CORPORATION]	Powerheart G3 Elite AED	2020-02-07
MKJ Cardiac Science [CARDIAC SCIENCE CORPORATION]	Powerheart G3 Elite AED	2020-02-07
MKJ CARDIAC SCIENCE CORPORATION	Powerheart G3 Elite AED	2020-02-07
PMA P160034S001 Cardiac Science Corporation	Powerheart® G3 Pro AED	2019-08-20
PMA P160033S004 CARDIAC SCIENCE CORPORATION	Powerheart® G3, G3 Plus and G5 AEDs	2019-08-20
PMA P160033S002 CARDIAC SCIENCE CORPORATION	Powerheart G5 Automated External Defibrillator	2019-07-25
PMN P160034 | MKJ CARDIAC SCIENCE CORPORATION	Powerheart G3 Pro AED	2019-05-24
PMN P160033 | MKJ CARDIAC SCIENCE CORPORATION	Powerheart G5 AED	2019-05-24
PMN P160033 | MKJ CARDIAC SCIENCE CORPORATION	Powerheart G3 Plus AED	2019-05-24
PMN P160033 | MKJ CARDIAC SCIENCE CORPORATION	Powerheart G3 AED	2019-05-24
GUDID 00812394021369 CARDIAC SCIENCE CORPORATION	Intellisense® Battery Powerheart® G5 XBTAED005A-TSO	2019-04-26
GUDID 00812394020997 CARDIAC SCIENCE CORPORATION	Intellisense™ Pediatric Defibrillation Pads Powerheart® G5G5 XELAED003B	2019-04-12
GUDID 00812394021420 CARDIAC SCIENCE CORPORATION	Powerheart® G5 TSO Kit, Semi, US EN/LA ESP CPRD G5S-80C-TSO	2019-04-08
GUDID 00812394021413 CARDIAC SCIENCE CORPORATION	Powerheart® G5 TSO Kit, Semi, US EN/LA ESP G5S-80A-TSO	2019-04-08
GUDID 00812394021406 CARDIAC SCIENCE CORPORATION	Powerheart® G5 TSO Kit, Auto, US EN/LA ESP, CPRD G5A-80C-TSO	2019-04-08
GUDID 00812394021390 CARDIAC SCIENCE CORPORATION	Powerheart® G5 TSO Kit, Auto, US EN/LA ESP G5A-80A-TSO	2019-04-08
PMA P160033S001 CARDIAC SCIENCE CORPORATION	Powerheart G5 AED	2018-12-20
PMA P160033 CARDIAC SCIENCE CORPORATION	Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3	2018-12-07
PMA P160034 Cardiac Science Corporation	Powerheart® AED G3 Pro	2018-12-06
GUDID 00812394021345 CARDIAC SCIENCE CORPORATION	Powerheart® G3 Pro Battery Charger Kit 9044-001	2018-07-06
GUDID 00812394021321 CARDIAC SCIENCE CORPORATION	Powerheart® MDLink 400621-046	2018-07-06
GUDID 00812394021314 CARDIAC SCIENCE CORPORATION	AED Manager, V.2.1.1.0 Powerheart G5 XAEDMGR01E	2018-07-06
GUDID 00812394021307 CARDIAC SCIENCE CORPORATION	Powerheart G5 Semi Auto G5S-80P1	2018-07-06
GUDID 00812394021291 CARDIAC SCIENCE CORPORATION	Powerheart G5, Semi, US Eng/ESP LA G5S-80-L	2018-07-06
GUDID 00812394021277 CARDIAC SCIENCE CORPORATION	Powerheart G5 Kit, Semi, US Eng/ESP LA G5S-80A	2018-07-06
GUDID 00812394021260 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Semi Automatic AED G5S-01P1	2018-07-06
GUDID 00812394021253 CARDIAC SCIENCE CORPORATION	Powerheart G5 Semi Automatic AED G5S-01-L	2018-07-06
GUDID 00812394021239 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Semi Automatic AED G5S-01A	2018-07-06
GUDID 00812394021222 CARDIAC SCIENCE CORPORATION	Powerheart G5 Auto G5A-80P1	2018-07-06
GUDID 00812394021215 CARDIAC SCIENCE CORPORATION	Powerheart G5, Auto, US Eng/ESP LA G5A-80-L	2018-07-06
GUDID 00812394021192 CARDIAC SCIENCE CORPORATION	Powerheart G5 Kit, Auto, US Eng/ESP LA G5A-80A	2018-07-06
GUDID 00812394021185 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Automatic AED G5A-01P1	2018-07-06
GUDID 00812394021178 CARDIAC SCIENCE CORPORATION	Powerheart G5 Automatic AED G5A-01-L	2018-07-06
GUDID 00812394021154 CARDIAC SCIENCE CORPORATION	Powerheart® G5 Automatic AED G5A-01A	2018-07-06
GUDID 00812394021147 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Semi Automatic 9390E-1001-TSO	2018-07-06
GUDID 00812394021130 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Semi Automatic Stocking Package 9390E-1001SP	2018-07-06
GUDID 00812394021123 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Semi Automatic 9390E-1001	2018-07-06
GUDID 00812394021116 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Semi-Automatic AED 9390E-01	2018-07-06
GUDID 00812394021109 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Automatic AED 9390A-1001-TSO	2018-07-06
GUDID 00812394021093 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Automatic AED, stocking package 9390A-1001SP	2018-07-06
GUDID 00812394021086 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Automatic AED 9390A-1001	2018-07-06
GUDID 00812394021079 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Plus Automatic AED 9390A-01	2018-07-06
GUDID 00812394021062 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Pro AED, Stocking Package 9300P-1001SP	2018-07-06
GUDID 00812394021055 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Pro AED 9300P-1001	2018-07-06
GUDID 00812394021048 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Pro 9300P-01	2018-07-06
GUDID 00812394021031 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Semi Automatic AED 9300E-1001-TSO	2018-07-06
GUDID 00812394021024 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Semi-Automatic AED 9300E-01	2018-07-06
GUDID 00812394021017 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Automatic AED 9300A-1001-TSO	2018-07-06
GUDID 00812394021000 CARDIAC SCIENCE CORPORATION	Powerheart® AED G3 Automatic AED 9300A-01	2018-07-06
GUDID 00812394020980 CARDIAC SCIENCE CORPORATION	Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 XELAED003A	2018-07-06
GUDID 00812394020959 CARDIAC SCIENCE CORPORATION	Intellisense Adult Defibrillation Pads, Powerheart® G5 XELAED001B	2018-07-06
GUDID 00812394020942 CARDIAC SCIENCE CORPORATION	Intellisense Adult Defibrillation Pads, Powerheart® G5 XELAED001A	2018-07-06
GUDID 00812394020935 CARDIAC SCIENCE CORPORATION	Powerheart® Pediatric Pads 9730-002	2018-07-06
GUDID 00812394020928 CARDIAC SCIENCE CORPORATION	Powerheart® Polarized Adult Defibrillation Pads 9660-001	2018-07-06
GUDID 00812394020911 CARDIAC SCIENCE CORPORATION	Powerheart® Adult Defibrillation Pads 9131-001	2018-07-06
GUDID 00812394020904 CARDIAC SCIENCE CORPORATION	Intellisense® Battery Powerheart® G5 XBTAED001A	2018-07-06
GUDID 00812394020898 CARDIAC SCIENCE CORPORATION	Powerheart® G3 TSO Battery 9147-201-TSO	2018-07-06
GUDID 00812394020881 CARDIAC SCIENCE CORPORATION	Powerheart® G3 Battery 9146-302	2018-07-06
GUDID 00812394020874 CARDIAC SCIENCE CORPORATION	Powerheart® G3 Battery 9146-301	2018-07-06
GUDID 00812394020867 CARDIAC SCIENCE CORPORATION	Powerheart® Pro Battery 9145-301	2018-07-06
GUDID 00812394020607 Cardiac Science Corporation	Powerheart®Pediatric Pads 2019199-003	2018-07-06
GUDID 00812394020560 Cardiac Science Corporation	Powerheart G5 Kit, Semi, US Eng/ESP LA G5S-80P0	2018-07-06
GUDID 00812394020539 Cardiac Science Corporation	AED Manager, V.2.0.5.0 Powerheart G5 XAEDMGR01C	2018-07-06
GUDID 00812394020515 Cardiac Science Corporation	Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 XELAED003B	2018-07-06
GUDID 00812394020492 Cardiac Science Corporation	Intellisense Adult Defibrillation Pads, Powerheart® G5 XELAED001B	2018-07-06
GUDID 00812394020379 Cardiac Science Corporation	Powerheart® AED G3 Plus Automatic AED 9390A-1001-TSO	2018-07-06
GUDID 00812394020362 Cardiac Science Corporation	Powerheart® AED G3 Plus Automatic AED 9390A-1001-SUNY	2018-07-06
GUDID 00812394020331 Cardiac Science Corporation	Powerheart® AED G3 Plus Automatic AED 9390A-01	2018-07-06
GUDID 00812394020256 Cardiac Science Corporation	Powerheart®Pediatric Pads 9730-002	2018-07-06
GUDID 00812394020232 Cardiac Science Corporation	Powerheart® AED G3 Plus Automatic AED 9390A-1001	2018-07-06
GUDID 00812394020171 Cardiac Science Corporation	Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 XELAED003A	2018-07-06
GUDID 00812394020164 Cardiac Science Corporation	Powerheart® G5 Automatic AED G5A-01P0	2018-07-06
GUDID 00812394020157 Cardiac Science Corporation	Powerheart® G5 Automatic AED G5A-01A	2018-07-06
GUDID 00812394020140 Cardiac Science Corporation	Powerheart® G5 Semi Automatic AED G5S-01A	2018-07-06
GUDID 00812394020133 Cardiac Science Corporation	Intellisense® Battery Powerheart® G5 XBTAED001A	2018-07-06
GUDID 00812394020126 Cardiac Science Corporation	Intellisense Adult Defibrillation Pads, Powerheart® G5 XELAED001A	2018-07-06
GUDID 00812394020041 Cardiac Science Corporation	Powerheart® G5 Semi Automatic AED G5S-01P0	2018-07-06
GUDID 00812394020065 Cardiac Science Corporation	Powerheart® AED G3 Automatic AED 9300A-1001-TSO	2018-03-29
GUDID 00812394020058 Cardiac Science Corporation	Powerheart® AED G3 Pro 9300P-01	2018-03-29
PMN K143714 CARDIAC SCIENCE CORPORATION	Powerheart G5 AED	2015-05-04
PMN K122758 CARDIAC SCIENCE CORPORATION	POWERHEART G5 AED	2014-02-12
PMN K113176 CARDIAC SCIENCE CORPORATION	MYSENSE HEART	2011-12-21
PMN K102496 CARDIAC SCIENCE CORPORATION	POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS	2011-06-09
PMN K093211 CARDIAC SCIENCE CORPORATION	CARECENTER MD	2010-06-03
PMN K091943 CARDIAC SCIENCE CORPORATION	POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A	2009-09-10
PMN K082090 CARDIAC SCIENCE CORPORATION	9131 DEFIBRILLATION ELECTRODES	2008-12-12
PMN K082173 CARDIAC SCIENCE CORPORATION	Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S	2008-08-26
PMN K060934 CARDIAC SCIENCE CORPORATION	MODIFICATION TO POWERHEART ECD	2006-05-15
PMN K060167 CARDIAC SCIENCE CORPORATION	ATRIA 3100, ATRIA 6100	2006-04-19
IKD CARDIAC SCIENCE CORPORATION	Powerheart AED G3 Pro ECG Monitoring Cable	1992-07-30

Related Finance Registrations

NCAGE Code	7WRR6	CARDIAC SCIENCE CORPORATION
NCAGE Code	4BGC2	CARDIAC SCIENCE CORP
NCAGE Code	4K9S5	CARDIAC SCIENCE CORPORATION
NCAGE Code	1CDW6	CARDIAC SCIENCE CORPORATION!DBA CARDIAC SCIENCE OPERATING!COMPANY
CAGE Code	1CDW6	CARDIAC SCIENCE CORPORATION CARDIAC SCIENCE OPERATING COMPANY
CAGE Code	4BGC2	CARDIAC SCIENCE CORP
CAGE Code	4K9S5	CARDIAC SCIENCE CORPORATION
CAGE Code	7WRR6	CARDIAC SCIENCE CORPORATION
S.A.M. Registration	7WRR6 [80355564]	CARDIAC SCIENCE CORPORATION
S.A.M. Registration	7WRR6 [80355564]	CARDIAC SCIENCE CORPORATION
DUNS	080355564	Cardiac Science Corporation
DUNS	190713797	Cardiac Science Corporation
SEC	0001323115	Cardiac Science CORP

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018112246931	Yantian,China (Mainland) -> Long Beach, California	MACHINERY PARTS,,INJECTION MOLD	22 PKG