Data / Medical devices / Mexico / Nordson MEDICAL Mexico
Nordson MEDICAL Mexico: FDA-registered device maker in Guaymas Sonora, Mexico, 10 510(k) clearances
Nordson MEDICAL Mexico is registered with the FDA (registration 3005448067) in Guaymas Sonora, Mexico. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 7, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005448067
- Address
- Carretera Internacional KM 129, Salida Norte, Sin Numero Parque Industrial Roca Fuerte, Guaymas Sonora, Mexico, CP 85400
- Owner or operator
- Nordson MEDICAL (CA), LLC (10027667)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- January 2, 2013
- Registered through
- 2026
- Brand names listed
- Applicator Tip, Malleable, Control Unit Regulator, Edwards Lifesciences Venous Drainage Cannulae, Endoscopic Applicator (0600125), Endoscopic Applicator (0600225), FibriJet 360 Endoscopic Applicator, FibriJet Applicator Assemblies, FibriJet Applicator Tip Dual Cannula and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 7, 2015 | K151543 | Graft Delivery Device with Integrated Stylet | FMF | Substantially Equivalent | Micromedics, Inc. (D/B/A Nordson Medical) | accessdata.fda.gov |
| January 8, 2013 | K123847 | MALLEABLE TIP ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| November 16, 2012 | K122526 | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| March 15, 2012 | K120608 | ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| March 15, 2011 | K102563 | SINGLE CANNULA EXTENDED APPLICATOR | KYZ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| September 13, 2006 | K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR | FMF | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| February 11, 2005 | K042834 | MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| October 4, 2004 | K033589 | BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR | FMF | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| October 29, 2001 | K012868 | MICROMEDICS FIBRIJET AEROSOL APPLICATOR | FMF | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| April 6, 1994 | K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | KYZ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Syringe, Piston
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Syringe, Irrigating (Non Dental)
Updated July 7, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.