Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183425

FEI Number

2183425

Entity Name

MICROMEDICS, INC.

City/State/Country

Saint Paul, MN, US

Establishment Address

1270 Eagan Industrial Road, Suite 120, Saint Paul, MN 55121, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Micromedics, Inc. (Owner Number: 2183425)

Owner / Operator Contact Address

1270 Eagan Industrial Road, Suite 120, Eagan, MN 55121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151543

PMA Number

N/A

All Registered Proprietary Names

Malleable Applicator Tip, Pramand Air-Assisted Sprayer, Flexure Malleable Tip Duplospray MIS Applicator with Snap Lock BAXTER DUPLOSPRAY MIS APPLICATOR MICROMEDICS BIOMATE MICROMEDICS BIOMATERIALS SPRAY SYRINGES Malleable Tip Endoscopic Applicator Endoscopic Applicator FibriJet Malleable Tip (SA-3690) ENDOSCOPIC CATHETER INTRODUCER MICROMEDICS FIBRIJET AIR AS Gasless Tip Applicator Micromedics FibriJet Aerosol Applic Gas Regulator with vent for laparoscopic procedures FibriJet Regulator DuploSpray MIS Regulator Graft Delivery, DePuy Synthes FibriJet Single Cannula Extended Applicator Gasless Tip Applicator Baxter Duplotip Surgical Sealant Ap Duplotip with Snap Lock OsteoPrecision LifeSpine Graft Delivery Device, Custom Cannula Arthrex BioXPress Graft Delivery, Integrated Stylet, Angle Tip,Vented, Arthrex Graft Delivery Device with Integrated Stylet, Graft Delivery Device Neck-Down

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-04-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2001-11-08
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	1997-11-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-03-21
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2009-04-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-12-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-04-07
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2012-06-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-12-20
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2011-06-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-04-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-09-23

Official Correspondent

Joel DeLaTorre

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Micromedics, 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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183425. Last updated year: 2026. Please use registration number 2183425 when referencing this establishment in official correspondence.