Zoll Circulation Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3010617000
• FEI Number: 3003793491
• Name: ZOLL Circulation, Inc.
• Owner & Operator: ZOLL MEDICAL CORPORATION
• Contact Address: 269 MILL ROAD ; Chelmsford MA 01824 US
• Official Correspondent:
  • PAUL - DIAS
  • x-978-4219413-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2000 Ringwood Ave ; San Jose, CA 95131 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 00849111075794 Zoll Circulation, Inc.	Thermogard XP, Lang set C, Rohs, Refurb	2023-12-18
GUDID 00849111075787 Zoll Circulation, Inc.	Thermogard XP, Lang set C, Rohs 601337-001	2023-12-18
GUDID 10849111002988 Zoll Circulation, Inc.	LifeBand® Load-distributing Band 8700-001013	2023-10-25
GUDID 00849111003032 Zoll Circulation, Inc.	AutoPulse NXT 8700-001018	2023-10-25
GUDID 00849111002998 Zoll Circulation, Inc.	AutoPulse Li-ion Battery 8700-001012	2023-10-25
GUDID 00849111002981 Zoll Circulation, Inc.	LifeBand® Load-distributing Band 8700-001013	2023-10-24
GUDID 00849111003568 Zoll Circulation, Inc.	AutoPulse NXT Multi-Chemistry Battery Charger 8700-001071	2023-10-23
GUDID 00849111003384 Zoll Circulation, Inc.	AutoPulse NXT Resuscitation System 8700-001070	2023-10-23
GUDID 00849111003049 Zoll Circulation, Inc.	AutoPulse NXT Resuscitation System 8700-001010	2023-10-23
GUDID 00849111003025 Zoll Circulation, Inc.	AutoPulse NXT Resuscitation System 8700-001017	2023-10-23
GUDID 00849111003018 Zoll Circulation, Inc.	AutoPulse NXT Resuscitation System 8700-001011	2023-10-23
GUDID 10849111003053 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0710	2022-08-23
GUDID 00849111003223 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0709	2022-08-23
GUDID 00849111075879 Zoll Circulation, Inc.	Thermogard HQTM Start-Up Kit EX 8700-001028-01	2022-07-05
GUDID 00849111075862 Zoll Circulation, Inc.	Thermogard HQTM Start-Up Kit 8700-001027-01	2022-07-05
GUDID 00849111075800 Zoll Circulation, Inc.	Thermogard HQTM Console 8700-001030-01	2022-07-05
PMN K220008 ZOLL Circulation, Inc	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogar	2022-06-02
GUDID 00849111065061 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-03	2020-02-06
GUDID 00849111065047 Zoll Circulation, Inc.	AutoPulse Charger 8700-0703-03	2020-02-06
GUDID 00849111002745 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-21	2020-02-06
GUDID 00849111002738 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-22	2020-02-06
GUDID 00849111002721 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-24	2020-02-06
GUDID 00849111002714 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-17	2020-02-06
GUDID 00849111002707 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-14	2020-02-06
GUDID 00849111002691 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-04	2020-02-06
GUDID 00849111002035 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-29	2020-02-06
GUDID 00849111002028 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-15	2020-02-06
GUDID 00849111002011 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-27	2020-02-06
GUDID 00849111002004 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-20	2020-02-06
GUDID 00849111001991 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-10	2020-02-06
GUDID 00849111001984 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-11	2020-02-06
GUDID 00849111001977 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-16	2020-02-06
GUDID 00849111001960 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-02	2020-02-06
GUDID 00849111001953 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-08	2020-02-06
GUDID 00849111001946 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger	2020-02-06
GUDID 00849111001939 Zoll Circulation, Inc.	AutoPulse Multi-Chemistry Battery Charger 8700-0753-01	2020-02-06
KFM ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	LifeBridge System	2019-06-02
KFM ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	LifeBridge Emergency Cardiopulmonary System	2019-06-02
KFM ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	LifeBridge 2.5 System	2019-06-02
KFM ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	LifeBridge 2.0 System	2019-06-02
GUDID 00849111030014 Zoll Circulation, Inc.	CoAxia FloControl™ Catheter 8700-000776-01	2019-03-21
GUDID 00849111030007 Zoll Circulation, Inc.	CoAxia NeuroFlo™ Catheter 8700-000775-01	2019-03-21
GUDID 00849111000635 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0730-20	2018-07-06
GUDID 00849111000628 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000611 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0730-10	2018-07-06
GUDID 00849111000604 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000598 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0730-11	2018-07-06
GUDID 00849111000581 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000574 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0730-16	2018-07-06
GUDID 00849111000567 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000550 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0730-02	2018-07-06
GUDID 00849111000543 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000536 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0730-08	2018-07-06
GUDID 00849111000529 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000512 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0730-01	2018-07-06
GUDID 00849111000505 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000499 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-02-66	2018-07-06
GUDID 00849111000482 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000475 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-27-66	2018-07-06
GUDID 00849111000468 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000451 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-21-66	2018-07-06
GUDID 00849111000444 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000437 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-22-66	2018-07-06
GUDID 00849111000420 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000413 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-24-66	2018-07-06
GUDID 00849111000406 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000390 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-20-66	2018-07-06
GUDID 00849111000383 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000376 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-10-66	2018-07-06
GUDID 00849111000369 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000352 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-11-66	2018-07-06
GUDID 00849111000345 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000338 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-16-66	2018-07-06
GUDID 00849111000321 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000314 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-02-66	2018-07-06
GUDID 00849111000307 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000291 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-08-66	2018-07-06
GUDID 00849111000284 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000277 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-01-66	2018-07-06
GUDID 00849111000260 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000253 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-22	2018-07-06
GUDID 00849111000246 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000239 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-10	2018-07-06
GUDID 00849111000222 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000215 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-15	2018-07-06
GUDID 00849111000208 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000192 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-29	2018-07-06
GUDID 00849111000185 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000178 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-20	2018-07-06
GUDID 00849111000161 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000154 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-11	2018-07-06
GUDID 00849111000147 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000130 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-08	2018-07-06
GUDID 00849111000123 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000116 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-02	2018-07-06
GUDID 00849111000109 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000093 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-21	2018-07-06
GUDID 00849111000086 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000079 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-16	2018-07-06
GUDID 00849111000062 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000055 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-27	2018-07-06
GUDID 00849111000048 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000031 Zoll Circulation, Inc.	AutoPulse®Resuscitation System 8700-0700-24	2018-07-06
GUDID 00849111000024 Zoll Circulation, Inc.	AutoPulse®Resuscitation System	2018-07-06
GUDID 00849111000017 Zoll Circulation, Inc.	AutoPulse® Resuscitation System 8700-0700-01	2018-07-06
PMN K150046 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Start-Up Kit (SUK)	2017-05-12
PMN K150046 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Quattro? Intravascular Heat Exchange Catheter	2017-05-12
PMN K150046 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	ICY? Intravascular Heat Exchange Catheter	2017-05-12
PMN K153226 ZOLL CIRCULATION, INC.	Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit	2016-03-24
PMN K150046 Zoll Circulation, Inc.	Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter	2015-10-30
PMN K080908 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	InnerCool RTx Endovascular System	2014-12-04
PMN K033623 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Celsius Control System	2014-12-04
FOH ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	InnerCool STx+ Surface Pads Set	2014-12-04
PMN K141139 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Solex Intravascular Heat Exchange Catheter	2014-10-28
PMN K090970 | MJN ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	FloControl Catheter 7F Model 1028	2013-12-06
PMN K072527 | DRM ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Autopulse Resuscitation System Model 100	2013-12-06
PMN H030005 | PAV ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	NeuroFlo Catheter Model 1027	2013-12-06
PMN K112998 | DRM ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	AutoPulse Recusitation System Model 100, AutoPulse Lithium-Ion Battery, AutoPulse Multi-Chemistry Battery Charger	2012-11-29
PMN K101987 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	ICY Catheter, Quattro Catheter, Cool Line Catheter	2012-11-29
PMN K081936 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Fortius Catheter	2009-05-08
PMN K072234 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Icy Model Catheter	2009-05-08
PMN K063829 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Cool Line Catheter	2009-05-08
PMN K060308 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	CoolGard 3000	2009-05-08
PMN K052443 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Thermogard	2009-05-08
PMN K051912 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Quattro Catheter	2009-05-08
PMN K030421 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Thermogard XP	2009-05-08
PMN K014241 | NCX ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	Solex Catheter	2009-05-08
PMN K063602 | DRM ZOLL Circulation, Inc. [ZOLL MEDICAL CORPORATION]	AutoPulse Resuscitation System Mode	2008-01-28

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092530170	Laem Chabang,Thailand -> Los Angeles, California	ELECTRIC CIRCUIT BOARDS	1 PKG
2020092241174	Hong Kong,Hong Kong -> Oakland, California	COVER, BELT, GUARD BELT CAP, BELT	21 PKG
202008224324	Yantian,China (Mainland) -> Oakland, California	COOLING FAN(WITHOUT BATTERY	15 CTN
2020081245530	Yantian,China (Mainland) -> Oakland, California	PVC CARRYING CASE	63 CTN
2020080820333	Yantian,China (Mainland) -> Oakland, California	COOLING FAN(WITHOUT BATTERY	15 CTN
2020073040574	Yantian,China (Mainland) -> Oakland, California	COOLING FAN(WITHOUT BATTERY	15 CTN
2020072941548	Yantian,China (Mainland) -> Oakland, California	COOLING FAN(WITHOUT BATTERY	15 CTN
2020070814009	Laem Chabang,Thailand -> Los Angeles, California	ELECTRIC CIRCUIT BOARDS	1 PKG