|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
promisemed blood lancet, verifine safety lancet, verifine mini-safety lancet
|
Promisemed Hangzhou Meditech Co., Ltd.
|
K192666 |
12/02/2019 |
emprint visualization application
|
Covidien LLC.
|
K192038 |
12/02/2019 |
ureteral stent open tip/closed tip/intraoperative tip, ureteral stent via ureterorenoscope open tip/closed tip, pediatric ureteral stent open tip/closed tip, mono j urinary diversion ureteral stent open tip/closed tip, multiloop ureteral stent open tip/closed tip
|
Allwin Medical Devices, Inc.
|
K190659 |
12/02/2019 |
uroject12 syringe lever
|
UroGen Pharma Ltd.
|
K190987 |
12/02/2019 |
resorbable mesh device
|
SeaSpine Orthopedics Corporation
|
K193040 |
11/30/2019 |
innonix antiviral child's face mask
|
Innonix Technologies Limited
|
K192105 |
11/29/2019 |
asahi crosswalk peripheral support catheter
|
Asahi Intecc Co., Ltd.
|
K192782 |
11/29/2019 |
i-portal neuro otologic test center, i-portal video nystagmography system, i-portal portable assessment system - nysragmograph
|
Neurolign USA, LLC
|
K192186 |
11/29/2019 |
axs infinity ls plus long sheath
|
Stryker Neurovascular
|
K193034 |
11/29/2019 |
elia symphonys immunoassay
|
Phadia AB
|
K190710 |
11/29/2019 |