APPLIED MEDICAL COATINGS

FDA Device Registration & Listing · Lockport, NY, US · Registration 3010353867

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010353867
FEI Number
3010353867
Entity Name
APPLIED MEDICAL COATINGS
City/State/Country
Lockport, NY, US
Establishment Address
230 South Niagara Street, Lockport, NY 14094, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Applied Medical Coatings (Owner Number: 10075212)
Owner / Operator Contact Address
230 South Niagara Street, Lockport, NY 14094, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MDS Needle Cautery Electrode (PTFE Coated) CardiPatch Cautery Electrode (Silicone Coated)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-03-31
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-06-09
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2023-10-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-06-09

Official Correspondent

Edward Robb

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Applied Medical Coatings
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
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

Similar Registrations

Registration Number Establishment Name Location
3007353760 ENERGIST LIMITED Swansea, GB
3005064998 RDI INC. Mount Kisco, NY, US
3020623326 TRIWORKS GROUP S.R.L. Palata Campobasso, IT
3012616488 BRERA MEDICAL INCORPORATED Northborough, MA, US
3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010353867. Last updated year: 2026. Please use registration number 3010353867 when referencing this establishment in official correspondence.
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