# Medtech S.A.S

- Location (FDA's records): Mauguio, FR
- FDA decisions: 4 (1999–2023): 4 510(k) clearances
- Names in FDA's records: Medtech S.A.S (3); Medtech , Ltd. (1)
- Product codes: HAW (3), GCJ (1)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtech S.A: 2 (https://510kreport.com/company/medtech-s-a)
- Medtronic Surgical Navigation: 1 (https://510kreport.com/company/medtronic-surgical-navigation)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- Integrated Surgical Systems, Inc.: 1 (https://510kreport.com/company/integrated-surgical-systems)

## Firms that cite its devices most
- Medtech S.A: 2 (https://510kreport.com/company/medtech-s-a)
- Applied Medical Resources: 1 (https://510kreport.com/company/applied-medical-resources)
- Mazor Robotics, Ltd.: 1 (https://510kreport.com/company/mazor-robotics)
- Imris, Inc.: 1 (https://510kreport.com/company/imris)

## Its most-cited devices
- K101791: Rosa Surgical Device (2010), cited by 4
- K214065: ROSA ONE Brain application (2022), cited by 1
- K990663: Intromit Hand Access Port for Hand Assisted Laparoscopic Surgery, Model FP880-150 (1999), cited by 1

## Recent decisions
- K231103: ROSA ONE Brain Application (Jul 20, 2023)
- K214065: ROSA ONE Brain application (May 4, 2022)
- K101791: Rosa Surgical Device (Sep 23, 2010)
- K990663: Intromit Hand Access Port for Hand Assisted Laparoscopic Surgery, Model FP880-150 (May 27, 1999)

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