Galil Medical Ltd
Country not established FDA
- Devices
- 77
- Registrations
- FDA
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Galil Medical Ltd makes
Galil Medical Ltd manufactures cryoablation devices, including the CRYO-HIT and CRYO-HIT II systems (models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5), IcePearl and IceForce cryoprobes (e.g., 2.1 CX L), and ICEROD CX cryoablation needles. Their portfolio also includes the SEEDNET and SEEDNET Gold systems (models GP6T5, GP5T5, FP6T5, FP5T5, etc.), designed for renal and other tissue ablation procedures, alongside related accessories like renal kits. Additional offerings include the ICESPHERE cryoblation needles (1.5 mm variants) and broader cryoablation platforms such as CRYOTHERA and SEEDNET/SEEDNET Gold combinations.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) registry, reflecting compliance with U.S. medical device authorization requirements. Galil Medical Ltd operates from the United States.
Catalogue
Search and filter all 77 devicesShowing 1-50 of 77
Company details
- DUNS number
- 531854560
- [email protected]
- Phone
- 651-287-5000
FDA recalls
FDA recall records list 7 recalls initiated by GALIL MEDICAL LTD, the earliest on 2007-12-11 and the most recent on 2019-10-25. By recorded status: 7 terminated. The reasons filed fall into these groups: software or firmware, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 25 Oct 2019 Z-0404-2020 Class II Terminated Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
Full distribution text
- 25 Oct 2019 Z-0404-2020 Class II Terminated Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
2012
- 20 Jul 2012 Z-2261-2012 Class II Terminated Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.
- 12 Apr 2012 Z-1613-2012 Not yet classified Terminated Galil Medical is recalling 17G Cryoablation Needle Holder, FPRPR 4014. This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders.
Full distribution text
2010
- 20 Dec 2010 Z-1031-2011 Unclassified (pre-2012) Terminated This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and Seednet MRI Systems, enabling the software to recognize if the channel on the system manifold is locked or unlocked. If an optocoupler is damaged or malfunction
Full distribution text
- 20 Dec 2010 Z-1032-2011 Unclassified (pre-2012) Terminated This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and Seednet MRI Systems, enabling the software to recognize if the channel on the system manifold is locked or unlocked. If an optocoupler is damaged or malfunction
Full distribution text
- 11 Nov 2010 Z-0832-2011 Unclassified (pre-2012) Terminated This voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be identified by a round ground pin and black plastic bridges. Cords with plugs that are not affected have U-shaped ground pins and no plastic bridges. Although Gali
- 20 Dec 2010 Z-1031-2011 Unclassified (pre-2012) Terminated This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and Seednet MRI Systems, enabling the software to recognize if the channel on the system manifold is locked or unlocked. If an optocoupler is damaged or malfunction
2007
- 11 Dec 2007 Z-1698-2008 Unclassified (pre-2012) Terminated The warming catheter was manufactured with the inlet and outlet tubes switched.
FDA establishments
- Galil Medical Ltd. YOKNEAM Northern · IL FEI 3002843919
Frequently asked questions
How many devices does GALIL MEDICAL LTD have in the registry?
The registry currently lists 77 devices for GALIL MEDICAL LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list GALIL MEDICAL LTD's devices?
Among its 50 most recently registered devices, GALIL MEDICAL LTD has devices listed in FDA 510(k) (4 devices) and FDA GUDID (46 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GALIL MEDICAL LTD's devices fall under?
Among its 50 most recently registered devices, the classes recorded for GALIL MEDICAL LTD's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for GALIL MEDICAL LTD?
FDA recall records list 7 recalls initiated by GALIL MEDICAL LTD, the most recent initiated on 2019-10-25. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from GALIL MEDICAL LTD in the registry?
The most recently registered devices listed for GALIL MEDICAL LTD include IceEDGE® 2.4 90° Cryoablation Needle FPRPR3506, EZ CONNECT2™ Dual Cylinder Adapter, bar FPRCH4001, MRI Mobile Unit FPRCH2030 and Single-Point 1.5 90° Thermal Sensor™ MultiPack FPRPR3206.
Which FDA establishments are linked to GALIL MEDICAL LTD?
1 FDA establishment is linked to GALIL MEDICAL LTD in the registry; they are listed on the company page.