# Combe, Inc.

- Location (FDA's records): White Plains, NY
- FDA decisions: 9 (1977–2017): 9 510(k) clearances
- Names in FDA's records: Combe, Inc. (6); Combe Incorporated (3)
- Product codes: NUC (3), EFT (2), EHS (1), KXX (1), KKX (1), KYS (1)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fidia Farmaceutici S.P.A.: 1 (https://510kreport.com/company/fidia-farmaceutici)

## Its most-cited devices
- K141718: Internal Hydrating Gel (2014), cited by 2
- K150615: Vaginal Moisturizing Gel (2015), cited by 1

## Recent decisions
- K171855: External Moisturizing Gel (Jul 21, 2017)
- K150615: Vaginal Moisturizing Gel (May 1, 2015)
- K141718: Internal Hydrating Gel (Nov 13, 2014)
- K942203: Otc Denture Cleanser (Aug 10, 1994)
- K925259: CFR Monograph (Jan 11, 1993)
- K863375: Sea-Bond (Sep 19, 1986)
- K780719: Fungus Fighter Insoles (Oct 10, 1978)
- K770413: Cushions, Denture Adhesive, All-Day (Jun 24, 1977)

Source page: https://510kreport.com/company/combe