Data / Medical devices / United States / Milestone Scientific, Inc.
Milestone Scientific, Inc.: FDA-registered device maker in Roseland, NJ, United States, 6 510(k) clearances
Milestone Scientific, Inc. is registered with the FDA (registration 3004082685) in Roseland, NJ, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 9, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004082685
- Address
- 425 Eagle Rock Ave., Roseland, NJ, United States, 07068
- Owner or operator
- MILESTONE SCIENTIFIC, INC. (9026774)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 21, 2006
- Registered through
- 2026
- Brand names listed
- CompuDent STA Handpiece, CompuDent STA System, CompuFlo Computer Controlled CathCheck Kit, CompuFlo Computer Controlled Epidural Disposable Kit, CompuFlo Epidural Controlled Anesthetic System, CompuFlo Syringe Pump, SAFETY Wand Disposable Handpiece, Safety Wand Disposable Handpiece and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion | FRN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 9, 2017 | K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | FMF | Substantially Equivalent | Milestone Scientific, Inc. | accessdata.fda.gov |
| August 8, 2006 | K061904 | COMPUDENT STA | EJI | Substantially Equivalent | Milestone Scientific, Inc. | accessdata.fda.gov |
| July 10, 2006 | K053554 | COMPUFLO | FRN | Substantially Equivalent | Milestone Scientific, Inc. | accessdata.fda.gov |
| September 2, 2003 | K023722 | SAFETYWAND DISPOSABLE HANDPIECE | EJI | Substantially Equivalent | Spintech, Inc. | accessdata.fda.gov |
| June 6, 2000 | K992404 | THE WAND | FMF | Substantially Equivalent | Spintech, Inc. | accessdata.fda.gov |
| July 5, 1996 | K961648 | THE WAND | EJI | Substantially Equivalent | Spintech, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 11, 2015 | 70742 | Class III | Terminated | Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled | Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument. | accessdata.fda.gov |
Compare with other makers
Updated June 9, 2017. 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.