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

FDA 510(k) cleared devices by Andersen Sterilizers, Inc. General Hospital ✕

19 devices
1-12 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
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