Nordson MEDICAL Mexico

FDA Device Registration & Listing · Guaymas Sonora, MX · Registration 3005448067

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
3005448067
FEI Number
3005448067
Entity Name
Nordson MEDICAL Mexico
City/State/Country
Guaymas Sonora, MX
Establishment Address
Carretera Internacional KM 129, Salida Norte, Sin Numero Parque Industrial, Roca Fuerte, Guaymas Sonora CP 85400, MX
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Nordson MEDICAL (CA), LLC (Owner Number: 10027667)
Owner / Operator Contact Address
7612 Woodwind Drive, Huntington Beach, CA 92647, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123847
PMA Number
N/A

All Registered Proprietary Names

FibriJet Topical Gas Assisted Applicator Tip FibriJet Gas Assisted Applicator Kit FibriJet Applicator Tip Dual Cannula ProtekSolo Transseptal (72 FR) FibriJet Endoscopic Catheter Introducer Applicator Tip, Malleable FibriJet Pole Clamp Graft Delivery Device Malleable Tip Applicators, Pramand Applicator Tip, Flexure™ Applicator Tip Graft Delivery, DePuy Synthes FibriJet Graft Delivery Device FibriJet OsteoPrecision Graft Delivery Device FibriJet Applicator Tips Dual Cannula, Malleable FibriJet Mixing Applicator Tips FibriJet Single Cannula Extended Applicators FibriJet Applicator Tip, Dual Channel Flexible Catheter FibriJet Single Chanel Mixing Applicators FibriJet Dual Spray Procedure Kit FibriJet Blending Connectors FibriJet Applicator Tip Single Spray FibriJet Applicators with Dual Spray FibriJet Applicator Assemblies FibriJet Applicator Tips Dual Cannula FibriJet Dual Spray Applicator Tip Endoscopic Applicator (0600225) Edwards Lifesciences Venous Drainage Cannulae Endoscopic Applicator (0600125) ProtekDuo Dual-Lumen (31 FR) ProtekSolo Transseptal FibriJet Applicator Tip Dual Lumen Cannula FibriJet 360 Endoscopic Applicator FibriJet Spray Set Endoscopic Applicator FibriJet Gas Assisted Endoscopic Applicator Spray Set FibriJet Spray Set Endoscopic Applicator FibriJet Endoscopic Applicator with Mixing Tip Control Unit Regulator FibriJet Regulators

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-03-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-03-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2019-11-05
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2016-03-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-12-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-03-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2015-11-23
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-12-06
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-12-06
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-01-02
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-03-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2015-11-23
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2019-11-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-03-22
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2016-03-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-06
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2017-04-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-06
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2019-11-05
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-01-02
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2019-11-05
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2016-03-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-03-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2017-04-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-03-22
CAN Regulator, Pressure, Gas Cylinder Anesthesiology Class 1 868.2700 2016-03-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-03-22

Official Correspondent

Ben Do

US Agent Details

Ben Do Business: Nordson Medical (CA), LLC Email: Ben.do@nordsonmedical.com Phone: (714) 3307454

Related Public Records

Same Entity

Nordson MEDICAL (CA), LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2032228 Nordson MEDICAL (CA), LLC Huntingtn Bch, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K832124 Med-West, Inc. CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI 1983-08-12
K162500 Spyder Medical Ostial Sprit Cannulae 2017-01-12
K914997 Conmedcorp ASP-IRRATOR 1992-01-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005448067. Last updated year: 2026. Please use registration number 3005448067 when referencing this establishment in official correspondence.
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