|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
clewicu system (clewicuserver and clewicunitor)
|
CLEW Medical Ltd.
|
K200717 |
01/09/2021
|
puritan bennett cuff pressure manager
|
Covidien llc
|
K202874 |
01/09/2021
|
acs ld uni fb knee system
|
Implantcast GmbH
|
K203341 |
01/08/2021
|
celerity 20 steam biological indicator for iuss
|
STERIS Corporation
|
K202721 |
01/08/2021
|
i-stat tbi plasma cartridge with the i-stat alinity system
|
Abbott Laboratories
|
K201778 |
01/08/2021
|
logiq p10, logiq p9, logiq p8
|
GE Medical Systems Ultrasound and Primary Care Diagnostics
|
K203114 |
01/08/2021
|
passion natural water based lubricant
|
XR LLC
|
K202017 |
01/08/2021
|
bioguard air/water and suction valves
|
STERIS Corporations
|
K203630 |
01/08/2021
|
button loop
|
Yunyi (Beijing) Medical Device Co., Ltd.
|
K202291 |
01/08/2021
|
heartflow analysis
|
HeartFlow, Inc.
|
K203329 |
01/08/2021
|