Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007544634

FEI Number

3007544634

Entity Name

Paragon Medical - Mansfield, Bridgemedica

City/State/Country

Mansfield, MA, US

Establishment Address

111 Forbes Blvd Suite 101, Mansfield, MA 02048, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PARAGON MEDICAL, INC. (Owner Number: 10041165)

Owner / Operator Contact Address

7800 Equitable Dr, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MAHURKAR Elite Acute Dual Lumen, Elite Acute Dual Lumen High Flow, Elite Acute Triple Lumen Catheter Kits and Trays TempSure Surfacer Inside-Out Catheter Access System Permcath Chronic Silicone Oval Catheter Kits MAHURKAR Acute High Pressure Triple Lumen Catheter Kits and Trays RELIZORB Permcath Chronic Silicone Oval Catheter Trays MAHURKAR Chronic Silicone Catheter Kits and Trays Perineologic Access Needle Precision Point Biopsy Needle Guide EFX002 Weck EFX Endo Fascial Closure System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2022-11-21
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-04-22
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-04-22
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2018-08-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-08-01
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-10-28
QJH	Reverse Central Venous Recanalization System	Cardiovascular	Class 2	870.1342	2023-12-21
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2014-04-22
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-04-22
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2021-04-16
PLQ	Enzyme Packed Cartridge	Gastroenterology, Urology	Class 2	876.5985	2016-02-08
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2022-11-21
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2014-04-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-04-22
KDW	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	Pathology	Class 1	864.3250	2024-03-27
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-04-13
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2017-12-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-12-14
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2016-02-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-05-07
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2017-12-14

Official Correspondent

Rob Macnamara

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PARAGON MEDICAL, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011445359	Paragon Medical - Southington	Southington, CT, US
1218017	LACEY MANUFACTURING COMPANY LLC	BRIDGEPORT, CT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0037-05	N/A	2	NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007544634. Last updated year: 2026. Please use registration number 3007544634 when referencing this establishment in official correspondence.