# Goodman Co., Ltd.

- Location (FDA's records): Nagoya, JP
- FDA decisions: 4 (2001–2025): 3 510(k) clearances and 1 original PMA approval
- Product codes: PNO (2), LLZ (1), NWX (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 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
- Spectranetrics: 1 (https://510kreport.com/company/spectranetrics)

## Its most-cited devices
- K232013: Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) (2024), cited by 1

## Recent decisions
- K243944: Aperta NSE PTA Balloon Dilatation Catheter (Apr 22, 2025)
- P230026: Lacrosse NSE ALPHA Coronary Dilatation Catheter (Jun 6, 2024)
- K232013: Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) (Mar 28, 2024)
- K010763: Goodnet (May 25, 2001)

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