Galil Medical Inc

FDA Filings

This page includes the latest FDA filings for Galil Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004462490
FEI Number3004462490
NameGALIL MEDICAL INC.
Owner & OperatorBoston Scientific Corporation
Contact Address300 Boston Scientific Way
Marlborough MA 01752 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address4364 Round Lake Road
Arden Hills, MN 55112 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Galil Medical Inc.
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)2020-07-09
GALIL MEDICAL INC.
ICEfx Cryoablation System FPRCH8000-022020-03-30
GALIL MEDICAL INC.
Visual-ICE® Cryoablation System FPRCH6000-022020-03-03
GALIL MEDICAL INC.
Visual-ICE® Cryoablation System FPRCH60002019-10-17
GALIL MEDICAL INC.
ICEfx Cryoablation System Cart FPRCH80102019-10-17
GALIL MEDICAL INC.
Visual-ICE MRI Mobile Connection Panel FPRCH71002019-10-17
GALIL MEDICAL INC.
Visual-ICE MRI Junction Box Assembly FPRCH7050 2019-10-17
GALIL MEDICAL INC.
Visual-ICE MRI Cryoablation Console FPRCH70002019-10-17
GALIL MEDICAL INC.
Supply Hose 4.5m w/o gauge FPRCH61242019-10-17
GALIL MEDICAL INC.
HE Supply Hose, 4.5m, psi FPRCH61212019-10-17
GALIL MEDICAL INC.
HE Supply Hose, 4.5m, bar FPRCH61202019-10-17
GALIL MEDICAL INC.
AR Supply Hose, 4.5m, psi FPRCH61192019-10-17
GALIL MEDICAL INC.
AR Supply Hose, 4.5m, bar FPRCH61182019-10-17
GALIL MEDICAL INC.
Argon Auxiliary Line (3 m) FPRCH61152019-10-17
GALIL MEDICAL INC.
Gas Supply Line (3 m) FPRCH61092019-10-17
GALIL MEDICAL INC.
Gas Supply Line (8 m) FPRCH61082019-10-17
GALIL MEDICAL INC.
Helium Supply Line (8 m), psi FPRCH61072019-10-17
GALIL MEDICAL INC.
Argon Supply Line (8 m), psi FPRCH61062019-10-17
GALIL MEDICAL INC.
Helium Supply Line (3 m), bar FPRCH61052019-10-17
GALIL MEDICAL INC.
Argon Supply Line (3 m), bar FPRCH61032019-10-17
GALIL MEDICAL INC.
Helium Supply Line (8 m), bar FPRCH61012019-10-17
GALIL MEDICAL INC.
Argon Supply Line (8 m), bar FPRCH61002019-10-17
GALIL MEDICAL INC.
EZ CONNECT2™ Dual Cylinder Adapter, bar FPRCH40012019-10-17
GALIL MEDICAL INC.
EZ CONNECT2™ Dual Cylinder Adapter, psi FPRCH40002019-10-17
GALIL MEDICAL INC.
ICEfx Cryoablation System FPRCH80002019-10-16
Galil Medical Inc.
ICEfx Cryoablation System2018-05-15
GALIL MEDICAL INC.
EZ CONNECT2™ Dual Cylinder Adapter (8 m), bar FRPCH40082018-03-29
GALIL MEDICAL INC.
EZ CONNECT2™ Dual Cylinder Adapter (8 m), psi FRPCH40072018-03-29
GALIL MEDICAL INC.
EZ CONNECT2™ Dual Cylinder Adapter, bar FRPCH40052018-03-29
GALIL MEDICAL INC.
EZ CONNECT2™ Dual Cylinder Adapter, psi FRPCH40042018-03-29
GALIL MEDICAL INC.
Helium Supply Line (8 m), bar FPRCH61402018-03-29
GALIL MEDICAL INC.
Helium Supply Line (8 m), psi FPRCH61392018-03-29
GALIL MEDICAL INC.
Argon Supply Line (8 m), bar FPRCH61382018-03-29
GALIL MEDICAL INC.
Argon Supply Line (8 m), psi FPRCH61372018-03-29
GALIL MEDICAL INC.
Argon Auxiliary Line (1.22 m) FPRCH61332018-03-29
GALIL MEDICAL INC.
Gas Supply Line (8 m) FPRCH61322018-03-29
GALIL MEDICAL INC.
Gas Supply Line (5 m) FPRCH61312018-03-29
GALIL MEDICAL INC.
Helium Supply Line (5 m), bar FPRCH61302018-03-29
GALIL MEDICAL INC.
Helium Supply Line (5 m), psi FPRCH61292018-03-29
GALIL MEDICAL INC.
Argon Supply Line (5 m), bar FPRCH61282018-03-29
GALIL MEDICAL INC.
Argon Supply Line (5 m), psi FPRCH61272018-03-29
Galil Medical Inc.
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel2017-11-21
GALIL MEDICAL INC.
Visual-ICE Cryoablation System, Software Revision 1.3.12015-03-05
GALIL MEDICAL INC.
VISUAL-ICE CRYOABLATION SYSTEM2013-02-06
GALIL MEDICAL INC.
VISUAL-ICE CRYOABLATION SYSTEM2012-03-12
GALIL MEDICAL INC.
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK2011-10-07

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