Medical Device Manufacturer · US , Haw River , NC

Andersen Sterilizers, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2015
19
Total
19
Cleared
0
Denied

Andersen Sterilizers, Inc. has 19 FDA 510(k) cleared general hospital devices. Based in Haw River, US.

Last cleared in 2022. Active since 2015.

Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Andersen Sterilizers, Inc.

19 devices
1-19 of 19
Cleared Apr 12, 2022
Anprolene SteriTest RRBI
K213296 · FRC
General Hospital · 193d
Cleared Mar 03, 2021
EOGas 4 Endo-SteriTest RRBI
K202879 · FRC
General Hospital · 156d
Cleared Nov 12, 2020
EOGas 4 Ethylene Oxide Gas Sterilizer
K192978 · FLF
General Hospital · 385d
Cleared Nov 12, 2020
EOGas 4 Endo-SteriTest
K192980 · FRC
General Hospital · 385d
Cleared Nov 12, 2020
AN1036 Dosimeter
K200334 · JOJ
General Hospital · 275d
Cleared Nov 12, 2020
Sterisheet Sterilization Wrap
K200335 · FRG
General Hospital · 275d
Cleared Nov 12, 2020
Tyvek Sterilization Pouches with Chevron Seal
K200336 · FRG
General Hospital · 275d
Cleared Nov 01, 2017
Sterisheet Sterilization Wrap
K170437 · FRG
General Hospital · 261d
Cleared Nov 01, 2017
AN87 Dosimeter
K170439 · JOJ
General Hospital · 261d
Cleared Oct 31, 2017
Anprolene SteriTest
K170427 · FRC
General Hospital · 260d
Cleared Oct 31, 2017
Anprolene AN75 Ethylene Oxide Gas Sterilizer
K170432 · FLF
General Hospital · 260d
Cleared Oct 30, 2017
AN85/AN86 EO Indicators
K170426 · JOJ
General Hospital · 259d
Cleared Oct 27, 2017
Tyvek Sterilization Pouches with Chevron Seal
K170429 · FRG
General Hospital · 256d
Cleared Dec 17, 2015
Sterisheet Sterilization Wrap
K152291 · FRG
General Hospital · 126d
Cleared Nov 19, 2015
AN1087 Dosimeter
K150645 · JOJ
General Hospital · 252d
Cleared Nov 18, 2015
AN85/AN86 EO Indicators
K150644 · JOJ
General Hospital · 251d
Cleared Nov 18, 2015
EOGas 4 Ethylene Oxide Gas Sterilizer
K150646 · FLF
General Hospital · 251d
Cleared Nov 18, 2015
Andersen EOGas 4 SteriTest
K151585 · FRC
General Hospital · 160d
Cleared Nov 18, 2015
Tyvek Sterilization Pouches with Chevron Seal
K152058 · FRG
General Hospital · 117d
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