Data / Medical devices / Australia / Becton Dickinson Pty Ltd
Becton Dickinson Pty Ltd: FDA-registered device maker in Macquarie Park New South Wales, Australia, 3 510(k) clearances
Becton Dickinson Pty Ltd is registered with the FDA (registration 3015983454) in Macquarie Park New South Wales, Australia. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 14, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015983454
- Address
- 66 Waterloo Road, Macquarie Park New South Wales, Australia, 2113
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Exporter to the US
- First device listed
- October 5, 2015
- Registered through
- 2026
- Brand names listed
- Gemini Sets, Medley Pump Sets, Alaris Pump Sets, Secondary Sets, Test set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 14, 1995 | K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET | FPA | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
| July 12, 1988 | K882302 | IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| May 29, 1979 | K790582 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
Compare with other makers
Updated February 14, 1995. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.