# The Surgical Company International B.V.

- Location (FDA's records): Beeldschermweg 6g, NL
- FDA decisions: 3 (2010–2025): 3 510(k) clearances
- Product codes: LGZ (2), DWJ (1)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cincinnati Sub-Zero Products, Inc.: 2 (https://510kreport.com/company/cincinnati-sub-zero-products)
- Adroit Medical Systems, Inc.: 1 (https://510kreport.com/company/adroit-medical-systems)
- Augustine Medical, Inc.: 1 (https://510kreport.com/company/augustine-medical)
- Vital Signs, Inc.: 1 (https://510kreport.com/company/vital-signs)

## Firms that cite its devices most
- The Surgical Company International BV (As the 37company): 1 (https://510kreport.com/company/surgical-company-international-as-the-37company)

## Its most-cited devices
- K101705: Mistral-Air Warming System (2010), cited by 1
- K211618: Fluido Compact Blood and Fluid Warming System (2023), cited by 1

## Recent decisions
- K252636: Fluido Compact System (Nov 18, 2025)
- K211618: Fluido Compact Blood and Fluid Warming System (Jun 5, 2023)
- K101705: Mistral-Air Warming System (Jul 2, 2010)

Source page: https://510kreport.com/company/surgical-company-international