Heartsine Technologies L T D

FDA Filings

This page includes the latest FDA filings for Heartsine Technologies L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004123209
• FEI Number: 3004123209
• Name: HEARTSINE TECHNOLOGIES, LTD
• Owner & Operator: STRYKER CORP.
• Contact Address: 1901 Romence Pkwy ; Portage MI 49002 US
• US Agent:
  • Kathryn Janecke
  • 425 8674660
  • kathryn.e.janecke@stryker.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 203 AIRPORT ROAD WEST ; BELFAST Northern Ireland, BT3 9ED GB
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID M727PADPAK07 HEARTSINE TECHNOLOGIES LTD	Pad-Pak Pad-Pak-07	2023-07-06
PMA P160008S016 HeartSine Technologies, Ltd.	samaritan Public Access Automated External Defibrillators and Accessories	2021-06-08
PMA P160008S015 HeartSine Technologies, Ltd.	samaritan Public Access Automated External Defibrillators and Accessories	2020-11-18
GUDID 05060167129773 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 450P 450-STR-AS-GW	2020-11-04
GUDID 05060167129735 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 360P 360-STR-AS-GW	2020-11-04
GUDID 05060167129711 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 350P 350-STR-AS-GW	2020-11-04
GUDID 05060167128066 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 360P 360-STR-US-GW	2020-11-04
GUDID 05060167120916 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 450P 450-STR-AS-10	2020-11-04
GUDID 05060167120893 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 350P 350-STR-AS-10	2020-11-04
GUDID 05060167120886 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 450P 450-STR-AS-AV	2020-11-04
GUDID 05060167120701 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 350P 350-STR-US-AV	2020-11-04
GUDID 05060167120695 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 450P 450-STR-US-10	2020-11-04
GUDID 05060167128080 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 450P 450-STR-US-GW	2020-11-02
GUDID 05060167128042 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 350P 350-STR-US-GW	2020-11-02
GUDID 05060167120909 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 360P 360-STR-AS-10	2020-11-02
GUDID 05060167120862 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 360P 360-STR-AS-AV	2020-11-02
GUDID 05060167120855 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 350P 350-STR-AS-AV	2020-11-02
GUDID 05060167120725 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 450P 450-STR-US-AV	2020-11-02
GUDID 05060167120718 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 360P 360-STR-US-AV	2020-11-02
GUDID 05060167120688 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 360P 360-STR-US-10	2020-11-02
GUDID 05060167120671 HEARTSINE TECHNOLOGIES LTD	HeartSine Samaritan PAD 350P 350-STR-US-10	2020-11-02
PMA P160008S014 HeartSine Technologies, Ltd.	HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories	2020-10-22
GUDID M727PADPAK02 HEARTSINE TECHNOLOGIES LTD	Pediatric-Pak PAD-PAK-02	2020-08-28
GUDID M727PADPAK01 HEARTSINE TECHNOLOGIES LTD	Pad-Pak PAD-PAK-01	2020-08-28
GUDID 05060167124488 HEARTSINE TECHNOLOGIES LTD	Pad-Pak PAD-PAK-07	2020-08-28
PMA P160008S012 HeartSine Technologies, Ltd.	HeartSine samaritan Public Access Automated External Defibrillators and Accessories	2020-07-17
PMA P160008S010 HeartSine Technologies, Ltd.	samaritan Public Access Automated External Defibrillators and Accessories	2020-03-12
PMA P160008S008 HeartSine Technologies, Ltd.	HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)	2020-01-09
PMA P160008S007 HeartSine Technologies, Ltd.	HeartSine’s samaritan Public Access Automated External Defibrillators and Accessories	2019-11-19
PMN P160008 | MKJ HEARTSINE TECHNOLOGIES, LTD [STRYKER CORP.]	Saver EVO	2017-12-07
PMN P160008 | MKJ HEARTSINE TECHNOLOGIES, LTD [STRYKER CORP.]	Pad-Pak-07	2017-12-07
PMN P160008 | MKJ HEARTSINE TECHNOLOGIES, LTD [STRYKER CORP.]	Pad-Pak-02	2017-12-07
PMN P160008 | MKJ HEARTSINE TECHNOLOGIES, LTD [STRYKER CORP.]	Pad-Pak-01	2017-12-07
PMN P160008 | MKJ HEARTSINE TECHNOLOGIES, LTD [STRYKER CORP.]	HeartSine samaritan PAD 450P (SAM 450P)	2017-12-07
PMN P160008 | MKJ HEARTSINE TECHNOLOGIES, LTD [STRYKER CORP.]	HeartSine samaritan PAD 360P (SAM 360P)	2017-12-07
PMN P160008 | MKJ HEARTSINE TECHNOLOGIES, LTD [STRYKER CORP.]	HeartSine samaritan PAD 350P (SAM 350P)	2017-12-07
OUG HEARTSINE TECHNOLOGIES, LTD [STRYKER CORP.]	HeartSine Gateway	2013-07-29

Similar & Related FDA Registered Companies

• HeartSine Technologies, Ltd.207 Airport Road Westbelfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS021 Date Received11/01/2022 Decision Date11/23/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• HeartSine Technologies, Ltd.207 Airport Road Westbelfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS020 Date Received08/29/2022 Decision Date11/23/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• HeartSine Technologies, Ltd.207 Airport Road Westbelfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS019 Date Received03/28/2022 Decision Date05/31/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	KCV79	HEARTSINE TECHNOLOGIES LTD
CAGE Code	KCV79	HEARTSINE TECHNOLOGIES LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202007258475	Belfast,United Kingdom -> Indianapolis, Indiana	DEFIBRILLATORS PACKED ON 20 PALLETS	20 PAL
20191009907	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	DEFIBRILLATORS PACKED ON 10 PALLETS	1280 PKG
20191003748	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	DEFIBRILLATORS	1200 PKG
2019081928430	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	DEFIBRILLATORS	1200 PKG
2019080523580	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	DEFIBRILLATORS PACKED ON 10 PALLETS	1280 PKG
2019080536488	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	DEFIBRILLATORS PACKED ON 10 PALLETS	1176 PKG
2019072531498	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	DEFIBRILLATORS PACKED ON 10 PALLETS	1280 PKG
2019072247223	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	DEFIBRILLATORS PACKED ON 10 PALLETS	1280 PKG