FDA 510(k) Applications Submitted by Amy Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K223678 |
12/08/2022 |
Sterile Syringes for Single Use |
Shanghai Kindly Enterprise Development Group Co., Ltd. |
| K161933 |
07/14/2016 |
The Braun ThermoScan« 3 High Speed Compact Ear Thermometer |
Kaz USA, Inc., A Helen of Troy Company |
| K191045 |
04/19/2019 |
SalvoÖ Spine System |
Spine Wave, Inc. |
| K181440 |
06/01/2018 |
Proficient« Posterior Cervical Spine System |
Spine Wave, Inc. |
| K181596 |
06/18/2018 |
Spine Wave Navigated Instruments |
Spine Wave, Inc. |
| K172175 |
07/19/2017 |
CapSure« PS System |
Spine Wave, Inc. |
| K202476 |
08/28/2020 |
Salvo« Spine System |
Spine Wave, Inc. |
| K172594 |
08/29/2017 |
Proficient« Posterior Cervical Spine System |
Spine Wave, Inc. |
| K192526 |
09/13/2019 |
Spine Wave Navigated Instruments |
Spine Wave, Inc. |
| K182954 |
10/24/2018 |
SalvoÖ Spine System |
Spine Wave, Inc. |
| K163246 |
11/18/2016 |
Leva Anterior Expandable Spacer System |
SPINE WAVE, INC. |
| K233741 |
11/22/2023 |
Hoffmann LRF System |
Stryker GmbH |
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