FDA 510(k) Applications Submitted by LYNNE A DAVIES
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140584 |
03/07/2014 |
ICEROD CX CRYOABLATION NEEDLE |
GALIL MEDICAL LTD. |
| K110946 |
04/04/2011 |
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE |
GALIL MEDICAL LTD. |
| K121251 |
04/25/2012 |
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK |
GALIL MEDICAL LTD. |
| K231691 |
06/09/2023 |
Phantom XL Insulated Dilators |
TeDan Surgical Innovations Inc. |
| K152133 |
07/31/2015 |
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 |
GALIL MEDICAL LTD |
| K162599 |
09/19/2016 |
IcePearl 2.1 CX L, IceForce 2.1 CX L |
GALIL MEDICAL LTD. |
| K173037 |
09/28/2017 |
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel |
Galil Medical Inc. |
| K030504 |
02/19/2003 |
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 |
IDEV TECHNOLOGIES, INC. |
| K041374 |
05/24/2004 |
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 |
IDEV TECHNOLOGIES, INC. |
| K033188 |
10/01/2003 |
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 |
IDEV TECHNOLOGIES, INC. |
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