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Combe, Inc.

FDA Regulatory Profile

Combe, Inc. has 0 FDA recalls, 3 inspections, 9 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 23, 2024 · NAI
Latest 510(k)
Jul 21, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances9Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 23, 2024White Plains, NYDevicesNo Action Indicated (NAI)2412672
Sep 17, 2021White Plains, NYDevicesNo Action Indicated (NAI)2412672
Jun 22, 2016White Plains, NYDevicesNo Action Indicated (NAI)2412672

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K171855External Moisturizing GelJul 21, 2017
K150615Vaginal Moisturizing GelMay 1, 2015
K141718INTERNAL HYDRATING GELNov 13, 2014
K942203OTC DENTURE CLEANSERAug 10, 1994
K925259CFR MONOGRAPHJan 11, 1993
K863375SEA-BONDSep 19, 1986
K780719FUNGUS FIGHTER INSOLESOct 10, 1978
K770413CUSHIONS, DENTURE ADHESIVE, ALL-DAYJun 24, 1977
K770175SEA-BOND ADHEVISE DENTURE CUSHIONSFeb 4, 1977

FDA data resources