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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
K200336Tyvek Sterilization Pouches with Chevron SealNovember 12, 2020
K200334AN1036 DosimeterNovember 12, 2020
K192978EOGas 4 Ethylene Oxide Gas SterilizerNovember 12, 2020
K200335Sterisheet Sterilization WrapNovember 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
K151585Andersen EOGas 4 SteriTestNovember 18, 2015
K150644AN85/AN86 EO IndicatorsNovember 18, 2015
K150646EOGas 4 Ethylene Oxide Gas SterilizerNovember 18, 2015
K152058Tyvek Sterilization Pouches with Chevron SealNovember 18, 2015