FDA 510(k) Applications Submitted by Li Lei
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220058 |
01/06/2022 |
BeneVision Central Monitoring System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K221113 |
04/15/2022 |
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K221267 |
05/02/2022 |
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
| K213799 |
12/06/2021 |
N Series Patient Monitors |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K050021 |
01/05/2005 |
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
| K050133 |
01/21/2005 |
D-STAT RADIAL HEMOSTATIC BAND |
VASCULAR SOLUTIONS, INC. |
| K050146 |
01/24/2005 |
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY |
VASCULAR SOLUTIONS, INC. |
| K050511 |
03/01/2005 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
| K200513 |
03/02/2020 |
DAC Dynamic Active Compression Plate |
Pioneer Surgical Technology, Inc., DBA RTI Surgical |
| K051287 |
05/18/2005 |
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
| K192718 |
09/27/2019 |
Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology |
Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc. |
| K053054 |
10/31/2005 |
THROMBIX 3X3 HEMOSTATIC PAD |
VASCULAR SOLUTIONS, INC. |
| K193468 |
12/16/2019 |
Tritium Sternal Cable Plate System |
Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) |
| K053644 |
12/30/2005 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
| K052965 |
10/21/2005 |
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. |
GUIDANT CORPORATION |
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