# Covidien, LLC, Formerly Registered AS Tyco Healthca

- Location (FDA's records): North Haven, CT
- FDA decisions: 2 (2010–2010): 2 510(k) clearances
- Product codes: GDW (1), NIE (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 26 (25 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Power Medical Interventions, Inc.: 2 (https://510kreport.com/company/power-medical-interventions)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Kendall: 1 (https://510kreport.com/company/kendall)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Covidien: 2 (https://510kreport.com/company/covidien)
- Covidien, Formerly US Surgical A Divison of Tyco H: 1 (https://510kreport.com/company/covidien-formerly-us-surgical-a-divison-of-tyco-h)
- Medcomp: 1 (https://510kreport.com/company/medcomp)
- Health Line International Corporation: 1 (https://510kreport.com/company/health-line-international)

## Its most-cited devices
- K102605: Mahurkar Triple Lumen Dialysis Catheter (2010), cited by 4
- K102325: Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) (2010), cited by 1

## Recent decisions
- K102605: Mahurkar Triple Lumen Dialysis Catheter (Dec 22, 2010)
- K102325: Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) (Oct 13, 2010)

Source page: https://510kreport.com/company/covidien-formerly-registered-as-tyco-healthca