Data / Medical devices / Mexico / Productos Urologos De Mexico S.A. De C.V.
Productos Urologos De Mexico S.A. De C.V.: FDA-registered device maker in MEXICALI Baja California, Mexico, 51 510(k) clearances
Productos Urologos De Mexico S.A. De C.V. is registered with the FDA (registration 8030673) in MEXICALI Baja California, Mexico. It lists 75 device types. The FDA files 51 510(k) clearances under its listings, the newest dated June 20, 2018. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8030673
- FEI number
- 3004213967
- Address
- CERRADA VIA DE LA PRODUCCION No. 85 PARQUE INDUST.MEXICALI III, MEXICALI Baja California, Mexico, 21397
- Owner or operator
- SunMed Group Holdings, LLC dba AirLife (10044795)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 1, 2013
- Registered through
- 2027
- Brand names listed
- ABSORBENT, CARBON-DIOXIDE, ACCESSORY, SURGICAL APPAREL, ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE, APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED, APPLICATOR, VAGINAL, Adapter Trach T, Adapters And Connectors (Ventilation Accessories), AirFlow Resuscitator 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 |
|---|---|---|---|---|---|---|
| June 20, 2018 | K173147 | SuperNO2VA Et Device | CCK | Substantially Equivalent | Revolutionary Medical Devices, Inc. | accessdata.fda.gov |
| October 13, 2017 | K163277 | SuperNO2VA Device | BSJ | Substantially Equivalent | Revolutionary Medical Devices, Inc. | accessdata.fda.gov |
| May 17, 2017 | K153748 | AirLife Misty Finity Nebulizer | CAF | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| July 7, 2016 | K153234 | AirLife Adult Heated Wire Circuit | BZE | Substantially Equivalent | Carefusion, Inc. | accessdata.fda.gov |
| January 21, 2016 | K151303 | AirLife Infant Heated Wire Circuit | BZE | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| January 20, 2016 | K151959 | AirLife Infant Single Limb Heated Wire Circuit | BZE | Substantially Equivalent | Carefusion, Inc. | accessdata.fda.gov |
| December 31, 2013 | K133806 | M1 CAPNOGRAPHY MASK | CCK | Substantially Equivalent | Monitor Mask, Inc. | accessdata.fda.gov |
| April 25, 2013 | K123527 | AIRLIFE | CAF | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| July 13, 2012 | K112840 | CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR | CCK | Substantially Equivalent | Seebreath AB | accessdata.fda.gov |
| May 4, 2012 | K120518 | END TIDAL CO2 NASAL CANNULA | CCK | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| January 26, 2011 | K101643 | MODEL LTV 1100 VENTILATOR | CBK | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| August 10, 2007 | K072119 | AIRLIFE NEBULIZER CAP | CAF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| June 10, 2004 | K041418 | AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER | CAF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| February 13, 2004 | K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | BZD | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| October 10, 2003 | K031195 | CUF-COVER (TM) | DXQ | Substantially Equivalent | Ethox Corp. | accessdata.fda.gov |
| May 2, 2003 | K023673 | AIRLIFE DEMAND NASAL CANNULA | NFB | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| May 1, 2003 | K023602 | SMALL VOLUME NEBULIZER | CAF | Substantially Equivalent | Allegiance Healthcare Corporation | accessdata.fda.gov |
| August 22, 2002 | K022402 | DISPOSABLE PRESSURE MANOMETER | CAP | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| March 30, 2000 | K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS | BZE | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| January 12, 1993 | K915226 | ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT | BZE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 6, 1993 | K914370 | MECONIUM SUCTION DEVICE (MSD) | BTR | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| July 23, 1992 | K921997 | CUFF-M | DXQ | Substantially Equivalent | Lorin Medical, Inc. | accessdata.fda.gov |
| March 11, 1992 | K914337 | GAS SAMPLING INTERFACES | CCK | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| November 1, 1991 | K911865 | NORTEC CONNECTING TUBE SET | GAZ | Substantially Equivalent | North American Sterilization & Packaging Co. | accessdata.fda.gov |
| October 18, 1991 | K911465 | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL | BZD | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| September 11, 1991 | K912578 | 20CM/H20 PEEP VALVE | BYE | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| August 2, 1991 | K912625 | MOUTH TO MASK RESUSCITATOR | BTM | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| June 18, 1991 | K910856 | MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| January 8, 1991 | K904874 | ADJUSTABLE PEEP VALVE | BYE | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| August 14, 1990 | K901728 | ONE-LUNG CPAP DEVICE | BYE | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| November 30, 1988 | K883964 | AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER | CAF | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 14, 1988 | K881086 | LIFEGUARD MOUTH TO MASK RESUSCITATOR | BTM | Substantially Equivalent | Lifeguard Medical Products, Inc. | accessdata.fda.gov |
| December 21, 1987 | K874395 | RESPIRGARD II NEBULIZER SYSTEM | CAF | Substantially Equivalent | Marquest Medical Products, Inc. | accessdata.fda.gov |
| April 5, 1985 | K850265 | AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE | CAH | Substantially Equivalent | American Pharmaseal Div. Ahsc | accessdata.fda.gov |
| May 14, 1984 | K840966 | ANESTHETIC GAS MONITOR SYS | CCK | Substantially Equivalent | Marquest Medical Products, Inc. | accessdata.fda.gov |
| September 12, 1983 | K831503 | DOWNS ADJUSTABLE FLOW GENERATOR | BYE | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| September 8, 1983 | K831885 | CODE BLUE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| March 2, 1982 | K820143 | XENON DELIVERY SYSTEM | IYT | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| August 25, 1981 | K812273 | RESUSCITATION CIRCUIT | BTM | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| September 9, 1980 | K802070 | VITAL SIGNS PEEP VALVE | BYE | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| June 4, 1980 | K801252 | NEBULIZER WITH AIR ENTERTAINER & ETC. | BTT | Substantially Equivalent | Airlife, Inc. | accessdata.fda.gov |
| March 25, 1980 | K800562 | DISPOSABLE HAND HELD NEBULIZER | CAF | Substantially Equivalent | Intec Medical, Inc. | accessdata.fda.gov |
| November 27, 1979 | K792218 | MISTY BEBULIZER | CAF | Substantially Equivalent | Airlife, Inc. | accessdata.fda.gov |
| September 26, 1979 | K791819 | AIR INCENTIVE SPIROMETER | BWF | Substantially Equivalent | Airlife, Inc. | accessdata.fda.gov |
| September 12, 1979 | K791558 | TEMP-STIK MODEL #300 | FLL | Substantially Equivalent | Temp-Stik Corp. | accessdata.fda.gov |
| August 28, 1979 | K791444 | UNIVERSAL TWO-PIECE MACHINES | CAF | Substantially Equivalent | Airlife, Inc. | accessdata.fda.gov |
| July 24, 1979 | K790892 | MISTY NEBULIZER | CAF | Substantially Equivalent | Airlife, Inc. | accessdata.fda.gov |
| June 13, 1979 | K791042 | I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL | CAF | Substantially Equivalent | Airlife, Inc. | accessdata.fda.gov |
| March 12, 1979 | K790151 | ONE-WAY VALVE | CBP | Substantially Equivalent | Airlife, Inc. | accessdata.fda.gov |
| October 31, 1978 | K781600 | MISTY-OX PREFILLED HUMIDIFIER, DISP. | BTT | Substantially Equivalent | Davco | accessdata.fda.gov |
| October 15, 1976 | K760585 | U-MID PREFILLED NEBULIZER | CAF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Compare with other makers
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- All makers of Tubing, Pressure And Accessories
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Conserver, Oxygen
Updated June 20, 2018. 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.