HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de R.L. de C.V.

FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3011163668

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
3011163668
FEI Number
3011163668
Entity Name
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de R.L. de C.V.
City/State/Country
Tijuana Baja California, MX
Establishment Address
Calle Maquiladoras No. 320-A, Col. Ciudad Industrial, Tijuana Baja California C.P. 22444, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HARMAC MEDICAL PRODUCTS, INC. (Owner Number: 1317547)
Owner / Operator Contact Address
2201 BAILEY AVE., --, Buffalo, NY 14211, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2022-12-05
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2007-12-20
HRX Arthroscope Orthopedic Class 2 888.1100 2013-08-20
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2007-12-20
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2023-10-26
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2020-08-03
HRX Arthroscope Orthopedic Class 2 888.1100 2015-10-20

Official Correspondent

Nathan Monin

US Agent Details

Nathan Monin Business: Harmac Medical Products Email: nmonin@harmac.com Phone: (716) 8974500

Related Public Records

Same Entity

HARMAC MEDICAL PRODUCTS, 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
3003630504 HARMAC MEDICAL PRODUCTS CASTLEREA Roscommon, IE
1317547 HARMAC MEDICAL PRODUCTS, INC. BUFFALO, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K902734 Olympus Corp. PR CANNULAS 1990-08-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011 Navilyst Medical, Inc 2
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011163668. Last updated year: 2026. Please use registration number 3011163668 when referencing this establishment in official correspondence.
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