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Andersen Sterilizers, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
1
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K213296Anprolene SteriTest RRBIApril 12, 2022
K202879EOGas 4 Endo-SteriTest RRBIMarch 3, 2021
K192978EOGas 4 Ethylene Oxide Gas SterilizerNovember 12, 2020
K200335Sterisheet Sterilization WrapNovember 12, 2020
K200336Tyvek Sterilization Pouches with Chevron SealNovember 12, 2020
K200334AN1036 DosimeterNovember 12, 2020
K192980EOGas 4 Endo-SteriTestNovember 12, 2020
K170439AN87 DosimeterNovember 1, 2017
K170437Sterisheet Sterilization WrapNovember 1, 2017
K170432Anprolene AN75 Ethylene Oxide Gas SterilizerOctober 31, 2017
K170427Anprolene SteriTestOctober 31, 2017
K170426AN85/AN86 EO IndicatorsOctober 30, 2017
K170429Tyvek Sterilization Pouches with Chevron SealOctober 27, 2017
K152291Sterisheet Sterilization WrapDecember 17, 2015
K150645AN1087 DosimeterNovember 19, 2015
K152058Tyvek Sterilization Pouches with Chevron SealNovember 18, 2015
K150644AN85/AN86 EO IndicatorsNovember 18, 2015
K151585Andersen EOGas 4 SteriTestNovember 18, 2015
K150646EOGas 4 Ethylene Oxide Gas SterilizerNovember 18, 2015