Data / Medical devices / Australia / Medical Developments International
Medical Developments International: FDA-registered device maker in Scoresby Victoria, Australia, 1 510(k) clearance
Medical Developments International is registered with the FDA (registration 3005977696) in Scoresby Victoria, Australia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 26, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005977696
- Address
- 4 Caribbean Drive, Scoresby Victoria, Australia, 3179
- Owner or operator
- Medical Developments International (10044454)
- Roles
- Manufacturer
- First device listed
- June 25, 2014
- Registered through
- 2027
- Brand names listed
- Antistatic Compact Space Chamber, Antistatic Silicone Face Mask - Large, Antistatic Silicone Face Mask - Medium, Antistatic Silicone Face Mask - Small, Asthma Chamber, Silicone Face Mask - Large, Silicone Face Mask - Medium, Silicone Face Mask - Small
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holding Chambers, Direct Patient Interface | NVP | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 26, 2016 | K143615 | Antistatic Compact Space Chamber | NVP | Substantially Equivalent | Medical Developments International Limited | accessdata.fda.gov |
Compare with other makers
Updated January 26, 2016. 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.