Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Zoll Circulation, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories4
Latest FDA decision2026-04-10
TypeNumberDevice NameCodeDateActions
PMA P170027 System, oxygen, aqueousMWG2026-04-10 View
510(k) K250979 Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)NZE2025-10-15 View
510(k) K231182 Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemNZE2023-11-03 View
510(k) K221700 AutoPulse NXT Resuscitation SystemDRM2023-03-09 View
510(k) K223746 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 ConsoleNCX2023-01-13 View
510(k) K220008 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, Thermogard HQ ConsoleNCX2022-06-02 View
510(k) K213031 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 ConsoleNCX2021-12-20 View
510(k) K153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX2016-03-24 View
↑