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 |
| K232674 |
09/01/2023 |
PainFreeze II |
Nuance Medical, LLC |
| K223763 |
12/15/2022 |
ZeptoLink IOL Positioning System |
Centricity Vision, Inc. |
| K223914 |
12/29/2022 |
ACTIVÖ Cap |
Cleansite Medical, 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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