Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219071

FEI Number

1000159144

Entity Name

MEDTRONIC XOMED, INC.

City/State/Country

Mystic, CT, US

Establishment Address

950 Flanders Rd, Mystic, CT 06355, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEROCEL SPONGES MEROCEL EYE WICKS MEROCEL AND KERACEL EYESPEARS Merocel Pope Oto Wicks Merocel Ear Packs, Post-Op Merocel Schindler Ear Packing Merocel Micro Spheres Merocel Ambrus Ear Packing Merocel Pope Ear Wicks MEROCEL SPONGE Neuray Surgical Patties and Strips NASAL SPLINT MEROCEL® HemoX Endoscopic Laparoscopic Visual Improvement Sponge (ELVIS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2007-12-27
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	1992-08-11
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	1995-04-18
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2007-12-27
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	1993-10-26
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2020-06-11
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2016-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, 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
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219071. Last updated year: 2026. Please use registration number 1219071 when referencing this establishment in official correspondence.