Data / Medical devices / Mexico / Covidien
Covidien: FDA-registered device maker in TIJUANA, B.C. Mexico, Mexico, 81 510(k) clearances
Covidien is registered with the FDA (registration 9610849) in TIJUANA, B.C. Mexico, Mexico. It lists 52 device types. The FDA files 81 510(k) clearances under its listings, the newest dated March 23, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9610849
- FEI number
- 3002807391
- Address
- Boulevard Insurgentes 19030 Libramiento, TIJUANA, B.C. Mexico, Mexico, 22225
- Owner or operator
- Covidien llc (1282497)
- Roles
- Contract manufacturer, Manufacturer, Reprocessor
- First device listed
- June 29, 1992
- Registered through
- 2027
- Brand names listed
- & Oximax Sensors, 3 & 4 Way Plastic Stopcocks, 3 and 4 Way Plastic Sterile Stopcoc, AGRYLE SALEM SUMP Nasogastric Tubes, ANTI-FOG, Acute and Chronic Catheter Repair Kit, Adult-Neonatal Adhesive Sensor Wrap, Adult-Neonatal Foam Sensor Wrap 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 |
|---|---|---|---|---|---|---|
| March 23, 2023 | K223488 | ClosureFast™ Endovenous Radiofrequency Ablation Catheter | GEI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 6, 2022 | K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC | DQA | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 17, 2021 | K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | CCK | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 15, 2021 | K210338 | Edge Insulated Blade Electrode | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| January 17, 2020 | K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter | MPB | Unknown | Covidien, LLC | accessdata.fda.gov |
| July 27, 2018 | K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender | FJS | Unknown | Covidien, LLC | accessdata.fda.gov |
| May 19, 2016 | K160290 | Valleylab REM Polyhesive Infant Patient Return Electrode | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 4, 2015 | K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 22, 2015 | K150108 | Reverse Medical Micro Vascular Plug System | KRD | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| June 18, 2014 | K141313 | REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM | KRD | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| November 27, 2013 | K133282 | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM | KRD | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| July 29, 2013 | K131361 | WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET | DWJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 2, 2013 | K123803 | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM | KRD | Substantially Equivalent | Reverse Medical Corporation | accessdata.fda.gov |
| January 31, 2013 | K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH | MSD | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 21, 2012 | K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | MSD | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| April 4, 2012 | K120674 | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER | MPB | Unknown | Covidien | accessdata.fda.gov |
| March 15, 2012 | K111933 | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 | BZQ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 9, 2011 | K111887 | CLOSUREFAST RADIOFREQUENCY CATHETER | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 30, 2011 | K111817 | PALINDROME RT CHRONIC CATHETER | MSD | Unknown | Covidien | accessdata.fda.gov |
| August 4, 2011 | K111372 | TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... | MSD | Unknown | Covidien | accessdata.fda.gov |
| November 19, 2009 | K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | NFK | Unknown | Kendall | accessdata.fda.gov |
| October 30, 2009 | K092205 | PALINDROME P HEMODIALYSIS CATHETER | MSD | Unknown | Covidien Lp, Formerly Registered AS Kendall | accessdata.fda.gov |
| October 15, 2008 | K082890 | VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 | GEI | Substantially Equivalent | Vnus Medical Technologies, Inc. | accessdata.fda.gov |
| August 1, 2006 | K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | GEI | Substantially Equivalent | Vnus Medical Technologies, Inc. | accessdata.fda.gov |
| July 22, 2005 | K051627 | VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT | GEI | Substantially Equivalent | Valleylab | accessdata.fda.gov |
| December 13, 2004 | K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | NLF | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| May 23, 2003 | K030930 | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| May 13, 2003 | K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | MPB | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| February 7, 2003 | K023494 | NELLCOR INDGO MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| September 27, 2002 | K022103 | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM | BZG | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| September 24, 2002 | K022819 | NELLCOR N-200 PULSE OXIMETER, MODEL N-200 | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| March 7, 2002 | K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| January 11, 2002 | K014121 | WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 | DWJ | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| September 6, 2000 | K002001 | BREEZE SLEEPGEAR WITH DREAMSEAL | BZD | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| March 7, 2000 | K994428 | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| November 24, 1999 | K993637 | N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| March 25, 1998 | K973419 | DMR PLUS DISPOSABLE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| December 5, 1996 | K964175 | VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| February 1, 1996 | K955836 | VALLEYLAB COATED ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 15, 1995 | K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| March 7, 1995 | K945964 | KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | LZH | Substantially Equivalent - Subject to Tracking Reg. | Sherwood Medical Co. | accessdata.fda.gov |
| February 10, 1995 | K950188 | VALLEYLAB COATED ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| October 17, 1994 | K944760 | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | DPZ | Substantially Equivalent | Nellcor, Inc. | accessdata.fda.gov |
| September 27, 1994 | K944400 | PEDI-CAP | CCK | Substantially Equivalent | Nellcor, Inc. | accessdata.fda.gov |
| September 20, 1994 | K944249 | AUTO SUTURE* ANTI-FOG DEVICE** | FEB | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 6, 1994 | K942246 | PURITAN-BENNETT NASAL CPAP MASK | BYE | Substantially Equivalent | Puritan-Bennett | accessdata.fda.gov |
| May 17, 1994 | K942183 | E2550 REUSABLE HANDSWITCHING PENCIL | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| October 6, 1993 | K933626 | CAPNO-FLO | BTM | Substantially Equivalent | Kirk Specialty Systems | accessdata.fda.gov |
| July 2, 1992 | K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 | BZQ | Substantially Equivalent | Edentec Corp. | accessdata.fda.gov |
| May 4, 1992 | K920515 | INSERTION | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| September 19, 1991 | K910786 | TROCAR (FALLER STYLET) | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| September 4, 1991 | K913016 | WARMTOUCH | DWJ | Substantially Equivalent | Advanced Warming Systems, Inc. | accessdata.fda.gov |
| December 31, 1990 | K904560 | VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 27, 1990 | K904039 | REFLECTANCE SENSOR (RS-10) | DQA | Substantially Equivalent | Nellcor, Inc. | accessdata.fda.gov |
| October 4, 1990 | K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS | FCM | Unknown | Superior Healthcare Group, Inc. | accessdata.fda.gov |
| March 27, 1989 | K890288 | PERITONEAL CATHETERS WITH AN ADDED FUNCTION | FJS | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| March 14, 1989 | K890193 | SINGLE PATIENT USE NASAL (CPAP) CIRCUIT | BYG | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| September 26, 1988 | K883201 | VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS | HBI | Substantially Equivalent | Vital Metrics, Inc. | accessdata.fda.gov |
| July 28, 1988 | K882097 | TUNNELING STYLET | DRB | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| May 18, 1987 | K871730 | MODIFIED USE OF PULL-APART INTRODUCER SET | FKO | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| August 19, 1986 | K862288 | MODIFICATION OF TISSUE DILATOR | DRE | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 19, 1986 | K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| May 6, 1986 | K861036 | E7509 POLYHESIVE II PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | 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 |
| July 26, 1985 | K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| July 24, 1985 | K841092 | HIGH PRESSURE FLEX. CONNECTING TUBING | DXT | Substantially Equivalent | Tronomed, Inc. | accessdata.fda.gov |
| May 17, 1985 | K844193 | QUINTON INJECTION SEALING CAP | FOZ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| November 8, 1984 | K840815 | LUER LOCKING ADAPTER(MATERIAL CHANGE) | FOZ | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| February 4, 1984 | K834062 | STERILE LABELS | LDQ | Substantially Equivalent | Devon Industries, Inc. | accessdata.fda.gov |
| March 29, 1983 | K830710 | ARGYLE SILICONE SALEM SUMP TUBE | KNT | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| September 21, 1982 | K822572 | POLYHESIVE PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 31, 1981 | K813488 | CATHETER REGULAR | FJS | Substantially Equivalent | Accurate Surgical Instruments Co. | accessdata.fda.gov |
| November 10, 1981 | K813071 | E2508 DISPOSABLE HANDSWITCHING PENCIL | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 17, 1980 | K802813 | PMR-2 PURITAN MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| October 23, 1980 | K802286 | ARGLE LATEX PENROSE TUBING | KGZ | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| July 14, 1980 | K801239 | STERILE, DISP DOME, INDIVID. PKG. | DRS | Substantially Equivalent | Pacific Domes, Inc. | accessdata.fda.gov |
| January 16, 1980 | K792128 | STERILE EXTENSION TUBES INDIV. PKG. | FMG | Substantially Equivalent | Tronomed, Inc. | accessdata.fda.gov |
| September 12, 1979 | K791639 | MODEL E2515 ELECTROSURGICAL ACCESSORY | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| May 16, 1978 | K780449 | BETA CAP SYSTEM | FJS | Substantially Equivalent | Quinton, Inc. | accessdata.fda.gov |
| June 14, 1977 | K770977 | CARDIOVASCULAR SPRING GUIDES | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| November 19, 1976 | K760923 | HUMIDIFIER-CASCADE II | BTT | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
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Updated March 23, 2023. 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.