Data / Medical devices / Mexico / Covidien
Covidien: FDA-registered device maker in Ciudad Juarez Chihuahua, Mexico, 47 510(k) clearances
Covidien is registered with the FDA (registration 9681384) in Ciudad Juarez Chihuahua, Mexico. It lists 24 device types. The FDA files 47 510(k) clearances under its listings, the newest dated December 29, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681384
- FEI number
- 3002807626
- Address
- Avenue Henequen No. 1181 Park Industrial Salvarcar, Ciudad Juarez Chihuahua, Mexico, 32573
- Owner or operator
- Covidien llc (1282497)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 1, 2003
- Registered through
- 2027
- Brand names listed
- 18860 6MM TAPERGUARD EVAC TRACHAEL, 18865 6.5MM TAPERGUARD EVAC TRACHEAL 202, 18870 7MM TAPERGUARD EVAC TRACHEAL, 18875 7.5MM TAPERGUARD EVAC TRACHEAL, 18880 8MM TAPERGUARD EVAC TRACHEAL, 18885 8.5MM TAPERGUARD EVAC TRACHEAL, 18890 9MM TAPERGUARD EVAC TRACHEAL, 4070 Temp Monitor 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 29, 2025 | K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | BZT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 20, 2024 | K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | FLL | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 20, 2024 | K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | BTR | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 30, 2023 | K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 22, 2019 | K182861 | Shiley Neonatal/Pediatric Tracheostomy Tube | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 22, 2019 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| February 15, 2019 | K183072 | EndoFLIP System | FFX | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| February 8, 2019 | K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| August 16, 2018 | K181020 | Cytosponge Cell Collection Device | EOX | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 22, 2017 | K172128 | EsoFLIP® ES-310 Balloon Catheter | PIE | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| December 11, 2015 | K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 14, 2015 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 24, 2015 | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 25, 2014 | K142000 | ESOFLIP ES | PIE | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| October 7, 2013 | K132337 | ESOFLIP BALLOON DILATION CATHETER | PID | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| October 9, 2012 | K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 3, 2009 | K090352 | TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 6, 2000 | K002001 | BREEZE SLEEPGEAR WITH DREAMSEAL | BZD | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| March 20, 1997 | K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| October 4, 1996 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| March 13, 1996 | K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| January 24, 1996 | K954749 | MALLINCKRODT SHILEY 15MM CAP | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| February 27, 1995 | K945407 | SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT | BTO | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| February 27, 1995 | K945406 | SSV PHONATE(TM) SHILEY SPEAKING VALVE | BTO | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| January 13, 1995 | K945513 | MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 11, 1994 | K941246 | RAE II TRACHEAL TUBE | BTR | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| July 2, 1993 | K930895 | SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF | JOH | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| March 26, 1993 | K925615 | SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE | CBI | Substantially Equivalent | Sorin Biomedica, Fiat, USA, Inc. | accessdata.fda.gov |
| May 8, 1992 | K914887 | ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT | FRQ | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| October 2, 1990 | K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| December 21, 1989 | K895875 | MODEL 4070 TEMPERATURE MONITOR | FLL | Substantially Equivalent | Mallinckrodt Anesthesia Products | accessdata.fda.gov |
| July 20, 1989 | K890194 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| March 14, 1989 | K890193 | SINGLE PATIENT USE NASAL (CPAP) CIRCUIT | BYG | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| January 17, 1989 | K884730 | SHILEY PERC TRACHEOSTOMY SYSTEM | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| January 29, 1988 | K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE | FLL | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| January 19, 1988 | K875234 | MON-A-THERM'S SKIN TEMPERATURE SENSOR | FLL | Substantially Equivalent | Mon-A-Therm, Inc. | accessdata.fda.gov |
| January 19, 1988 | K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | CAO | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| April 21, 1987 | K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| January 3, 1986 | K852632 | GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB | CAI | Substantially Equivalent | Medicomp, Inc. | accessdata.fda.gov |
| October 19, 1984 | K843730 | SHILEY DISPOS. DECANNULATION PLUG W/SW/ | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| July 26, 1984 | K841872 | UNCUFFED REINFORCED TRACHEAL TUBE | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| August 10, 1983 | K831567 | FOLEY-TEMP | KOD | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| July 10, 1981 | K811862 | HI-LO TEMP ESOPHAGEAL STETHOSCOPE | BZT | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| June 26, 1981 | K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| June 13, 1979 | K791045 | MODEL GV-10 LANZ PRESSURE-VALVE | BTR | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. | accessdata.fda.gov |
| July 19, 1976 | K760125 | AIRWAY, ARGYLE NASOPHARYNGEAL | BTQ | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
| July 16, 1976 | K760137 | TUBE, FEEDING, ARGYLE | FPD | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
Compare with other makers
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Updated December 29, 2025. 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.