FDA 510(k) Applications Submitted by Neal Hartman
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K210310 |
02/03/2021 |
CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit |
Nuance Medical, LLC |
K200400 |
02/18/2020 |
Systane iLux2 |
Tear Film Innovations, Inc. |
K220677 |
03/08/2022 |
Kurin Blood Culture Collection Set with Kurin Lock Technology |
Kurin, Inc, |
K210827 |
03/19/2021 |
ZEPTO Precision Capsulotomy System |
Centricity Vision, Inc. |
K221188 |
04/25/2022 |
ZEPTO Precision Capsulotomy System |
Centricity Vision, Inc. |
K191832 |
07/09/2019 |
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) |
Kurin, Inc |
K223763 |
12/15/2022 |
ZeptoLink IOL Positioning System |
Centricity Vision, Inc. |
K040066 |
01/13/2004 |
SIREMOBILE C06 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K040347 |
02/12/2004 |
SIREMOBIL ISO-C 3D |
SIEMENS MEDICAL SYSTEMS, INC. |
K040577 |
03/04/2004 |
SOMATOM PROJECT P30L |
SIEMENS MEDICAL SYSTEMS, INC. |
K041111 |
04/28/2004 |
MAGNETOM C! MR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K041112 |
04/28/2004 |
MAGNETOM ESPREE SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K032280 |
07/24/2003 |
SIREMOBIL ISO-C 3D |
SIEMENS AG |
K032428 |
07/29/2003 |
MAGNETOM AVANTO MR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K032475 |
08/12/2003 |
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K042229 |
08/17/2004 |
SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE |
SIEMENS MEDICAL SOLUTION, INC. USA |
K042328 |
08/27/2004 |
SOMATOM SPIRIT |
SIEMENS MEDICAL SYSTEMS, INC. |
K042617 |
09/24/2004 |
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
K042718 |
09/30/2004 |
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA |
SIEMENS MEDICAL SOLUTIONS, INC. |
K033238 |
10/06/2003 |
MOBILETTE XP AND MOBILETT XPHYBRID |
SIEMENS MEDICAL SYSTEMS, INC. |
K043030 |
11/03/2004 |
MAGNETOM C! MR SYSTEM |
SIEMENS MEDICAL SOLUTIONS |
K040665 |
03/04/2004 |
SOMATOM SENSATION 64 AND SENSATION CARDIAC |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
K032536 |
08/18/2003 |
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
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