ZOLL

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• zoll.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• LifeVest® Wearable Defibrillator

  2023-01-19

  ZOLL MANUFACTURING CORPORATION121 Gamma Drpittsburgh, PA 15238-0000 PMA NumberP010030 Supplement NumberS163 Date Received01/09/2023 Decision Date01/19/2023 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

• LifeVest® Wearable Defibrillator

  2022-08-18

  ZOLL MANUFACTURING CORPORATION121 Gamma Drpittsburgh, PA 15238-0000 PMA NumberP010030 Supplement NumberS160 Date Received08/03/2022 Decision Date08/18/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

• LifeVest Wearable Defibrillator

  2022-06-01

  ZOLL MANUFACTURING CORPORATION121 Gamma Drpittsburgh, PA 15238-0000 PMA NumberP010030 Supplement NumberS159 Date Received05/17/2022 Decision Date06/01/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

• AED Plus

  2022-05-27

  ZOLL MEDICAL CORPORATION269 & 271 Mill Roadchelmsford, MA 01824 PMA NumberP160015 Supplement NumberS014 Date Received05/20/2022 Decision Date05/27/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...

• AED Plus

  2022-03-01

  ZOLL MEDICAL CORPORATION269 & 271 Mill Roadchelmsford, MA 01824 PMA NumberP160015 Supplement NumberS013 Date Received02/23/2022 Decision Date03/01/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...

• LifeVest® Wearable Defibrillator

  2022-01-25

  ZOLL MANUFACTURING CORPORATION

• LifeVest® Wearable Defibrillator

  2021-12-03

  ZOLL MANUFACTURING CORPORATION

• LifeVest® Wearable Defibrillator

  2021-11-04

  ZOLL MANUFACTURING CORPORATION

• LifeVest® Wearable Defibrillator

  2021-10-12

  ZOLL MANUFACTURING CORPORATION

• LifeVest Wearable Defibrillator

  2021-09-17

  ZOLL MANUFACTURING CORPORATION

• LifeVest Wearable Defibrillator

  2021-09-01

  ZOLL MANUFACTURING CORPORATION

• AED 3, AED Plus

  2021-08-13

  ZOLL MEDICAL CORPORATION

• Powerheart G5 AED

  2021-06-14

  ZOLL Medical Corporation

• X Series Advanced s

  2021-05-19

  ZOLL MEDICAL CORPORATION

• LifeVest Wearable Defibrillator

  2021-05-17

  ZOLL MANUFACTURING CORPORATION

• LifeVest Wearable Defibrillator

  2021-05-17

  ZOLL MANUFACTURING CORPORATION

• LifeVest Wearable Defibrillator

  2021-04-26

  ZOLL MANUFACTURING CORPORATION

• X Series, R Series, Propaq MD, and AED Pro

  2021-03-26

  ZOLL MEDICAL CORPORATION

• ZOLL AED 3 and ZOLL AED 3 Automatic

  2021-03-18

  ZOLL MEDICAL CORPORATION

• ZOLL AED 3 BLS

  2021-03-18

  ZOLL MEDICAL CORPORATION

• AED Plus

  2021-03-09

  ZOLL MEDICAL CORPORATION

• Powerheart® G5 AED

  2021-02-02

  ZOLL Medical Corporation

• R Series

  2021-01-05

  ZOLL MEDICAL CORPORATION

• X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

  2021-01-05

  ZOLL MEDICAL CORPORATION

• ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes

  2020-12-30

  ZOLL MEDICAL CORPORATION

• ZOLL CPR Uni-padz

  2020-12-30

  ZOLL MEDICAL CORPORATION

• Zoll AED 3

  2020-12-21

  ZOLL MEDICAL CORPORATION

• X Series, R Series, and AED Pro

  2020-12-07

  ZOLL MEDICAL CORPORATION

• LifeVest Wearable Defibrillator

  2020-11-05

  ZOLL MANUFACTURING CORPORATION

• ZOLL AED Plus and ZOLL Fully Automatic AED Plus

  2020-10-07

  ZOLL MEDICAL CORPORATION

• X Series, Propaq MD, and R Series

  2020-09-29

  ZOLL MEDICAL CORPORATION

• LifeVest Wearable Defibrillator

  2020-09-17

  ZOLL MANUFACTURING CORPORATION

• AED 3 BLS

  2020-09-17

  ZOLL MEDICAL CORPORATION

• LifeVest Wearable Defibrillator

  2020-07-02

  ZOLL MANUFACTURING CORPORATION

• LifeVest Wearable Defibrillator

  2020-06-17

  ZOLL MANUFACTURING CORPORATION

• X Series and Propaq MD

  2020-06-11

  ZOLL MEDICAL CORPORATION

• AED 3 Defibrillator with Uni-Padz

  2020-06-05

  ZOLL MEDICAL CORPORATION

• LifeVest Wearable Defibrillator

  2020-05-14

  ZOLL MANUFACTURING CORPORATION

• LifeVest Wearable Defibrillator

  2020-04-18

  ZOLL MANUFACTURING CORPORATION

• LifeVest Wearable Defibrillator

  2020-04-16

  ZOLL MANUFACTURING CORPORATION

179 records. Showing 1-40. Next

PMN#

• 731 Series Ventilator

  2024-12-13

  ZOLL Medical Corporation

• Thermogard HQ? Temperature Management System, Thermogard XP® Temperature Management System

  2023-11-03

  Zoll Circulation, Inc.

• AutoPulse NXT Resuscitation System

  2023-03-09

  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 XP Console, Thermogard HQ Console

  2023-01-13

  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

  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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

  2021-12-20

  Zoll Circulation, Inc.

• ZOLL Propaq M

  2021-03-09

  ZOLL Medical Corporation

• ZOLL Arrhythmia Management Sysyem

  2019-12-19

  ZOLL Manufacturing Corporation

• ZOLL ECG Analysis Software

  2019-01-28

  ZOLL Manufacturing Corporation

• ZOLL Propaq M

  2018-11-30

  ZOLL Medical Corporation

• Power Infuser

  2018-07-18

  ZOLL Medical Corporation

• µCor Heart Failure And Arrhythmia Management System

  2018-05-11

  ZOLL Manufacturing Corporation

• 731 Series Ventilators

  2017-08-02

  ZOLL MEDICAL CORPORATION

• Model 330 Multifunction Aspirator

  2017-04-18

  ZOLL Medical Corporation

• Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

  2016-03-24

  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

  Zoll Circulation, Inc.

• ZOLL E SERIES

  2015-01-16

  ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

• ZOLL X Series

  2014-12-03

  ZOLL MEDICAL CORPORATION

• ZOLL X SERIES

  2014-11-19

  ZOLL MEDICAL CORPORATION

• ZOLL E SERIES ALS

  2014-11-06

  ZOLL MEDICAL CORPORATION

• SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER

  2014-10-03

  ZOLL CIRCULATION

• ZOLL X SERIES

  2014-08-01

  ZOLL MEDICAL CORP.

• ZOLL X SERIES

  2014-05-22

  ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

• ZOLL CODE WRITER

  2014-04-03

  ZOLL MEDICAL CORPORATION

• ZOLL EPCR IOS

  2013-12-17

  ZOLL MEDICAL CORPORATION

• ZOLL SUREPOWER SINGLE BAY CHARGER

  2012-12-13

  ZOLL MEDICAL CORPORATION

• ZOLL RESCUENET 12-LEAD

  2012-11-20

  ZOLL MEDICAL CORPORATION

• ZOLL FULLY AUTOMATIC AED PLUS

  2012-10-26

  ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

• ZOLL R SERIES

  2012-09-25

  ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

• ZOLL PROPAQ XM

  2012-06-21

  ZOLL MEDICAL CORPORATION

• POCKETCPR

  2012-05-10

  ZOLL MEDICAL CORP.

• ZOLL PROPAQ MD

  2012-04-25

  ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

• ZOLL X SERIES

  2012-03-21

  ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

• AUTOPULSE RESUSCITATION SYSTEM MODEL 1000

  2012-03-15

  ZOLL CIRCULATION

• ZOLL RESCUENETLINK

  2011-10-27

  ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

• ZOLL E SERIES

  2011-08-17

  ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

• ONESTEP PEDIATRIC MFE'S

  2011-05-13

  ZOLL MEDICAL CORPORATION

• ZOLL RESCUENET EPCR MODEL RESCUENET EPCR

  2011-05-13

  ZOLL MEDICAL CORPORATION

• ONESTEP ADULT MULTI-FUNCTION ELECTRODE

  2011-04-13

  ZOLL MEDICAL CORPORATION

• ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

  2011-03-25

  ZOLL MEDICAL CORPORATION

99 records. Showing 1-40. Next

GUDID#

• VitalTemp™ - VitalTemp™ Universal Pad, 2PK, US

  Zoll Circulation, Inc.

  2025-12-12

• VitalTemp™ - VitalTemp™ Universal Pad, 2PK, US

  Zoll Circulation, Inc.

  2025-12-12

• Thermogard™ Vest, L/XL - L/XL

  Zoll Circulation, Inc.

  2024-05-22

• Thermogard™ Vest, S/M - S/M

  Zoll Circulation, Inc.

  2024-05-22

• ThermoGard XP Surface Start-Up Kit - The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature.

  Zoll Circulation, Inc.

  2024-05-22

• Thermogard HQ Surface Start-Up Kit - "The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature."""

  Zoll Circulation, Inc.

  2024-05-22

• STX SURFACE COOLING - STX SURFACE COOLING Pad THIGHS ONLY PAD SET

  Zoll Circulation, Inc.

  2024-08-15

• STX SURFACE COOLING - STX SURFACE COOLING Pad L/XL PAD SET

  Zoll Circulation, Inc.

  2024-08-15

• STX SURFACE COOLING - STX Surface Cooling Pad

  Zoll Circulation, Inc.

  2024-08-15

• Thermogard XP, Lang set B, Rohs, Refurb - The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

  Zoll Circulation, Inc.

  2015-07-01

• Thermogard XP, Lang set A, Rohs, Refurb - The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

  Zoll Circulation, Inc.

  2015-07-01

• Thermogard XP, Lang set A, Non-Rohs, Refurb - The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

  Zoll Circulation, Inc.

  2015-07-01

• Solex 7 CO Kit, Applause Custom Luer - The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

  Zoll Circulation, Inc.

  2015-06-30

• QUATTRO® Intravascular Heat Exchange Catheter Applause Custom Luer - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-06-30

• ICY® Intravascular Heat Exchange Catheter Kit Applause Custom Luer - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-06-30

• Cool Line® Intravascular Heat Exchange Catheter Applause Custom Luer - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

  Zoll Circulation, Inc.

  2015-06-30

• Quattro, Heparin, Premium Kit, US - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-07-30

• RTX CIRCULATING CASSETTE WITHOUT ELECTROLYTE - The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters.

  Zoll Circulation, Inc.

  2015-07-01

• RTX CIRCULATING CASSETTE WITH ELECTROLYTE - The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters.

  Zoll Circulation, Inc.

  2015-07-01

• CATHETER INTRODUCER KIT, 10.7F - An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter.

  Zoll Circulation, Inc.

  2015-07-01

• CATHETER INTRODUCER KIT, 14F - An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.

  Zoll Circulation, Inc.

  2015-07-01

• 14F PACKAGED ACCUTROL CATHETER - The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).

  Zoll Circulation, Inc.

  2015-07-01

• 10.7F PACKAGED ACCUTROL CATHETER - The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).

  Zoll Circulation, Inc.

  2015-07-01

• InnerCool RTx 14F Standard Catheter - An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.

  Zoll Circulation, Inc.

  2015-07-01

• InnerCool RTx 10.7F Standard Catheter - An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter.

  Zoll Circulation, Inc.

  2015-07-01

• Hospital Monitoring Interface Accessory - Hospital Monitoring Interface Accessory (HIMIA) 8 Pin provides patient temperature signal from the Alsius System to a bedside patient monitoring system.

  Zoll Circulation, Inc.

  2015-03-31

• Hospital Monitoring Interface Accessory - Hospital Monitoring Interface Accessory (HIMIA) 8 Pin provides patient temperature signal from the Alsius System to a bedside patient monitoring system.

  Zoll Circulation, Inc.

  2015-03-31

• Start-Up Kit Extended Length, Custom Luer - 9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

  Zoll Circulation, Inc.

  2015-07-15

• Start-Up Kit Extended Length - 9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

  Zoll Circulation, Inc.

  2015-03-31

• Start-Up Kit Custom Luer - 6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

  Zoll Circulation, Inc.

  2015-07-15

• Start-Up Kit - 6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

  Zoll Circulation, Inc.

  2015-03-31

• SOLEX® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EU - The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

  Zoll Circulation, Inc.

  2015-07-30

• SOLEX® Intravascular Heat Exchange Catheter Primum Kit Custom Luer Applause Hep - The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

  Zoll Circulation, Inc.

  2015-07-30

• QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin) - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-07-30

• QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin E - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-07-30

• QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non-Hep - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-07-30

• ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin) - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-07-30

• ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin) - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-07-30

• ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non Heparin - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

  Zoll Circulation, Inc.

  2015-07-30

• Cool Line® Intravascular Heat Exchange Catheter Kit EU Final Packaged Kit Custom - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

  Zoll Circulation, Inc.

  2015-07-30

80 records. Showing 1-40. Next