This page includes the latest FDA filings for Galil Medical L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 9616793 |
| FEI Number | 3002843919 |
| Name | GALIL MEDICAL LTD. |
| Owner & Operator | Boston Scientific Corporation |
| Contact Address | 300 Boston Scientific Way Marlborough MA 01752 US |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | YOKNEAM GATE, 1 TAVOR BLDG. YOKNEAM Ha Zafon, 20692 IL |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| GALIL MEDICAL LTD | MultiPoint 1.5 Thermal Sensor FPRPR4020-02 | 2020-11-09 |
| GALIL MEDICAL LTD | MultiPoint 1.5 Thermal Sensor FPRPR4020 | 2020-08-24 |
GALIL MEDICAL LTD. [Boston Scientific Corporation] | CryoHit Cryoablation System | 2019-10-11 |
GALIL MEDICAL LTD. [Boston Scientific Corporation] | CryoHit Cryoablation System | 2019-10-11 |
| GALIL MEDICAL LTD | IceSphere™ 1.5 CX Cryoablation Needle FPRPR3573 | 2018-10-23 |
Galil Medical Ltd. | IceSphere 1.5 CX Cryoablation Needle | 2018-07-30 |
| GALIL MEDICAL LTD | IceFORCE™ 2.1 CX L 90⁰ Cryoablation Needle FPRPR3618 | 2018-07-06 |
| GALIL MEDICAL LTD | IcePearl™ 2.1 CX L 90⁰ Cryoablation Needle FPRPR3617 | 2018-07-06 |
| GALIL MEDICAL LTD | Three IcePearl® 2.1 CX Prostate Cryoablation KitVi FPRPR3608 | 2018-07-06 |
| GALIL MEDICAL LTD | Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit FPRPR3607 | 2018-07-06 |
| GALIL MEDICAL LTD | IcePearl® 2.1 CX Prostate Cryoablation Kit / Visua FPRPR3606 | 2018-07-06 |
| GALIL MEDICAL LTD | IceFORCE® 2.1 CX Prostate Cryoablation Kit / Visua FPRPR3605 | 2018-07-06 |
| GALIL MEDICAL LTD | IceFORCE® 2.1 CX Cryoablation Needle FPRPR3604 | 2018-07-06 |
| GALIL MEDICAL LTD | IcePearl® 2.1 CX Cryoablation Needle FPRPR3603 | 2018-07-06 |
| GALIL MEDICAL LTD | IceFORCE® 2.1 CX 90⁰ Cryoablation Needle FPRPR3602 | 2018-07-06 |
| GALIL MEDICAL LTD | IcePearl® 2.1 CX 90⁰ Cryoablation Needle FPRPR3601 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® i-Thaw® Prostate Cryoablation Kit / Visual FPRPR3572 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSphere® 1.5 90° Cryoablation Needle FPRPR3560 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSphere® 1.5 Cryoablation Needle FPRPR3558 | 2018-07-06 |
| GALIL MEDICAL LTD | MRI SeedNet®Gold Console FPRCH2033 | 2018-07-06 |
| GALIL MEDICAL LTD | MRI Mobile Unit for MRI CryoHit system FPRCH2032 | 2018-07-06 |
| GALIL MEDICAL LTD | MRI Mobile Unit FPRCH2030 | 2018-07-06 |
| GALIL MEDICAL LTD | IceEDGE® 2.4 90⁰ Cryoablation Needle FPRPR3506 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® 1.5 CX 90° Cryoablation Needle FPRPR3533 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® 1.5 PLUS Cryoablation Needle FPRPR3510 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® 1.5 PLUS 90° Cryoablation Needle FPRPR3508 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSphere® 1.5 S 90° Cryoablation Needle FPRPR3561 | 2018-07-06 |
| GALIL MEDICAL LTD | Prostate Procedure Template SPR000018 | 2018-07-06 |
| GALIL MEDICAL LTD | Galil Medical Urethral Warming Set FPRPR4003 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSphere® Cryoablation Needle FPRPR3261 | 2018-07-06 |
| GALIL MEDICAL LTD | Single-Point 1.5 90° Thermal Sensor™ MultiPack FPRPR3206 | 2018-07-06 |
| GALIL MEDICAL LTD | Single-Point 1.5 Thermal Sensor™ MultiPack FPRPR3212 | 2018-07-06 |
| GALIL MEDICAL LTD | Multi-Point 1.5 Thermal Sensor™ FPRPR4010 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® 1.5 MRI 90° Cryoablation Needle FPRPR3195 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSeed® 1.5 MRI 90° Cryoablation Needle FPRPR3194 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® 1.5 MRI Cryoablation Needle FPRPR3193 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSeed® 1.5 MRI Cryoablation Needle FPRPR3192 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSphere® 1.5 90° Cryoablation Needle FPRPR3260 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® 1.5 90° Cryoablation Needle FPRPR3204 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSeed® 1.5 90° Cryoablation Needle FPRPR3202 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSphere® 1.5 Cryoablation Needle FPRPR3258 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® 1.5 i-Thaw® Cryoablation Needle FPRPR4009 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® 1.5 Cryoablation Needle FPRPR3203 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSeed® 1.5 Cryoablation Needle FPRPR3201 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® i-Thaw® Prostate Cryoablation Kit / Presic FPRPR4070 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® He-Thaw Prostate Cryoablation Kit / Presic FPRPR4570 | 2018-07-06 |
| GALIL MEDICAL LTD | IceRod® Prostate Cryoablation Kit / SeedNet® Syste FPRPR3070 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSeed® Prostate Cryoablation Kit / Presice® Syst FPRPR4518 | 2018-07-06 |
| GALIL MEDICAL LTD | IceSeed® Prostate Cryoablation Kit / SeedNet® Syst FPRPR3008 | 2018-07-06 |
| GALIL MEDICAL LTD | MRI SeedNet®Gold Cryoablation System FPRCH2035 | 2018-07-06 |
GALIL MEDICAL LTD. | IcePearl 2.1 CX L, IceForce 2.1 CX L | 2016-10-11 |
GALIL MEDICAL LTD | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System | 2015-08-28 |
GALIL MEDICAL LTD. | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE | 2014-07-02 |
GALIL MEDICAL LTD. | ICEROD CX CRYOABLATION NEEDLE | 2014-03-31 |
GALIL MEDICAL LTD. | ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK | 2012-08-28 |
GALIL MEDICAL LTD. | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE | 2011-06-21 |
GALIL MEDICAL LTD. | ISIS | 2007-03-20 |
GALIL MEDICAL LTD. | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA | 2006-04-27 |
GALIL MEDICAL LTD. | SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS | 2006-02-13 |
GALIL MEDICAL LTD. | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA | 2005-11-18 |
GALIL MEDICAL LTD. | SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) | 2005-05-06 |
GALIL MEDICAL LTD. | SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) | 2004-10-14 |
GALIL MEDICAL LTD. | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM | 2003-05-23 |
GALIL MEDICAL LTD. | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | 2002-07-03 |
GALIL MEDICAL LTD. | SEEDNET, MODEL FP6T5, FP5T5, FP5T3 | 2002-01-29 |
GALIL MEDICAL LTD. | CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 | 2001-10-30 |
GALIL MEDICAL LTD. | SEEDNET, MODELS FP6T5, FP5T5, FP5T3 | 2001-05-03 |
GALIL MEDICAL LTD. | SEEDNET, MODEL EP6T5, EP5E5 | 2000-10-31 |
GALIL MEDICAL LTD. | CRYO-HIT | 2000-02-18 |
GALIL MEDICAL LTD. | CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 | 1999-07-27 |
GALIL MEDICAL LTD. | CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E | 1999-07-12 |
GALIL MEDICAL LTD. | CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 | 1998-07-01 |
| NCAGE Code | 3742A | GALIL MEDICAL LTD |
| CAGE Code | 3742A | GALIL MEDICAL LTD |
| SEC | 0001452991 | Galil Medical Ltd of ISRAEL |