Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027296681

FEI Number

3027296681

Entity Name

MGDINNOVATIONS INC. (MGDI)

City/State/Country

Tampa, FL, US

Establishment Address

3001 West Swann Avenue, Tampa, FL 33609, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MGD Innovations Inc. (MGDi) (Owner Number: 10087864)

Owner / Operator Contact Address

3001 West Swann Avenue, Tampa, FL 33609, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Maskin MG Probe 2mm Maskin MG Probe 1mm Maskin MG Probe 4mm Maskin MG Microtube Maskin MG Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-04-21

Official Correspondent

Steven Maskin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MGD Innovations Inc. (MGDi)

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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3034992373	PLU OPHTHALMIC Corp	Coral Gables, FL, US
3031572059	TissueGUARD	Dresden Saxony, DE
3008754084	Belle Healthcare Technology Co., Ltd.	Suzhou Jiangsu, CN
3008719017	SUMMIT MEDICAL LLC	Saint Paul, MN, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027296681. Last updated year: 2026. Please use registration number 3027296681 when referencing this establishment in official correspondence.