Data / Medical devices / Mexico / WESTMED de Mexico, S.A de C.V.
WESTMED de Mexico, S.A de C.V.: FDA-registered device maker in Tecate Baja California, Mexico, 17 510(k) clearances
WESTMED de Mexico, S.A de C.V. is registered with the FDA (registration 9710644) in Tecate Baja California, Mexico. It lists 22 device types. The FDA files 17 510(k) clearances under its listings, the newest dated December 14, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710644
- FEI number
- 3003949221
- Address
- BLVD ENCINO 100 Parque Industrial Tecate, Tecate Baja California, Mexico, 21430
- Owner or operator
- WESTMED, INC. (9048311)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- January 8, 2004
- Registered through
- 2026
- Brand names listed
- Anapod, Anesthesia Breathing Circuit Kit, ApnealInk ResMed Cannula, Breathing Bag, CLEAR ANESTHESIA BRE, Circulaire System, Clear Anesthesia, Flexi-lim and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| December 14, 2016 | K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| December 6, 2012 | K121382 | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] | CAH | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| August 23, 2007 | K072220 | PEDI CO2 EASY | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| February 15, 2007 | K070128 | CO2 EASY | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| July 22, 2004 | K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | CAP | Substantially Equivalent | Ambu, Inc. | accessdata.fda.gov |
| June 3, 2004 | K040712 | AIR SAFETY HEPA, MODEL 3500 | MOD | Substantially Equivalent | Air Safety, Ltd. | accessdata.fda.gov |
| March 11, 1998 | K973238 | ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER | CAH | Substantially Equivalent | Bill Olson Corp. | accessdata.fda.gov |
| December 28, 1995 | K954271 | WESTMED CONDESATE COLLECTION TRAP | CAW | Substantially Equivalent | Westmed Intl. | accessdata.fda.gov |
| April 24, 1995 | K951484 | WESTMED BACTERIAL/VIRAL FILTER | CAH | Substantially Equivalent | Westmed Intl. | accessdata.fda.gov |
| July 23, 1993 | K932709 | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM | BZR | Substantially Equivalent | Precision Med Products, Ltd. | accessdata.fda.gov |
| February 3, 1993 | K926055 | THE MILLER NEBULIZER SYSTEM | CAF | Substantially Equivalent | Warren C. Miller | accessdata.fda.gov |
| August 24, 1992 | K922492 | SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER | CAH | Substantially Equivalent | Specialty Packaging Producs, Inc. | accessdata.fda.gov |
| August 3, 1992 | K923618 | PEEP VALVE | BYE | Substantially Equivalent | International Respiratory Systems, Inc. | accessdata.fda.gov |
| February 3, 1992 | K913163 | NON REBREATHING VALVE | CBP | Substantially Equivalent | Specialty Packaging Producs, Inc. | accessdata.fda.gov |
| April 24, 1991 | K904538 | MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT | CAI | Substantially Equivalent | Mauna Loa Medical, Inc. | accessdata.fda.gov |
| June 10, 1988 | K881451 | SIMPLEX UNIVERSAL HEATED TUBING SLEEVE | BZE | Substantially Equivalent | Simplex Medical Corp. | accessdata.fda.gov |
| April 3, 1987 | K870173 | LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL | BTT | Substantially Equivalent | Mauna Loa Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
- All makers of Cannula, Nasal, Oxygen
- All makers of Mask, Oxygen
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Generator, Oxygen, Portable
Updated December 14, 2016. 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.