Milestone Scientific, Inc.
Roseland, NJ, US
MILESTONE SCIENTIFIC, INC. appears in FDA device records in Roseland, NJ. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Milestone Scientific, Inc. between 2006 and 2023. The busiest year on record is 2006, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2017 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | FMF | Substantially Equivalent | |
| K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | FMF | Substantially Equivalent | |
| K061904 | COMPUDENT STA | EJI | Substantially Equivalent | |
| K053554 | COMPUFLO | FRN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004082685 | 3004082685 | MILESTONE SCIENTIFIC, INC. | 425 Eagle Rock Ave., Roseland, NJ 07068 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1952-2015 | 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 dental injection system. | Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain