Zoll Circulation, Inc.
Zoll Circulation, Inc. holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2025, with 33 FDA device recalls on record.
Top product codes for Zoll Circulation, Inc.
FDA recalls by Zoll Circulation, Inc.
10 most recent of 33- Z-1533-2025 — Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A
- Z-0118-2023 — AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
- Z-0053-2022 — Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
- Z-0042-2022 — ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
- Z-0055-2022 — Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
- Z-0043-2022 — ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
- Z-0060-2022 — Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
- Z-0054-2022 — Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173
- Z-0062-2022 — Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
- Z-0039-2022 — Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Zoll Circulation, Inc.
- K250979 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
- K231182 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
- K221700 — AutoPulse NXT Resuscitation System
- 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 Console
- 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 Console
- 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 Console
- K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
- K150046 — Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.