# Tomen America, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 1 (2003–2003): 1 510(k) clearance
- Product codes: NOZ (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 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
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)

## Firms that cite its devices most
- Diazyme Laboratories: 1 (https://510kreport.com/company/diazyme-laboratories)

## Its most-cited devices
- K031604: Glycomark (2003), cited by 1

## Recent decisions
- K031604: Glycomark (Sep 22, 2003)

Source page: https://510kreport.com/company/tomen-america