Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004082685

FEI Number

3004082685

Entity Name

MILESTONE SCIENTIFIC, INC.

City/State/Country

Roseland, NJ, US

Establishment Address

425 Eagle Rock Ave., Roseland, NJ 07068, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MILESTONE SCIENTIFIC, INC. (Owner Number: 9026774)

Owner / Operator Contact Address

425 Eagle Rock AVE., Suite 403, Roseland, NJ 07068, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K992404

PMA Number

N/A

All Registered Proprietary Names

The Wand Computer Controlled Anesthetic Delivery System CompuFlo Epidural Controlled Anesthetic System The Wand Handpiece The Wand Plus System CompuFlo Computer Controlled CathCheck Kit CompuDent STA Handpiece SAFETY Wand Disposable Handpiece CompuDent STA System CompuFlo Computer Controlled Epidural Disposable Kit CompuFlo Syringe Pump The CompuFlo Epidural Computer Controlled Anesthesia System The Wand Handpiece Syringe CompuDent STA Handpiece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2007-11-01
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2006-07-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-11-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-04-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MILESTONE SCIENTIFIC, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

Similar Registrations

Registration Number	Establishment Name	Location
1058726	RUMEX INTERNATIONAL CO.	Tampa, FL, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3008242564	Septodont, Inc	Lancaster, PA, US
3012507533	Integra Canada ULC	Oakville Ontario, CA
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004082685. Last updated year: 2026. Please use registration number 3004082685 when referencing this establishment in official correspondence.