Data / Medical devices / Mexico / Avent S. de R.L. de C.V.
Avent S. de R.L. de C.V.: FDA-registered device maker in TIJUANA Baja California, Mexico, 49 510(k) clearances
Avent S. de R.L. de C.V. is registered with the FDA (registration 9680425) in TIJUANA Baja California, Mexico. It lists 23 device types. The FDA files 49 510(k) clearances under its listings, the newest dated January 31, 2025. Registered through 2026. FDA data exported November 3, 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
- 9680425
- FEI number
- 3007596547
- Address
- Ave Noruega Edificio D-1B Fraccionamiento, Rubio, TIJUANA Baja California, Mexico, 22116
- Owner or operator
- Avanos Medical, Inc. (2022573)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 14, 2007
- Registered through
- 2026
- Brand names listed
- 220266MIL, 220316, 220342, 220343, 220344, 220404, 220405, 220451 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 |
|---|---|---|---|---|---|---|
| January 31, 2025 | K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | IRP | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| May 19, 2022 | K210983 | BD Epilor Syringe | CAZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 22, 2020 | K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | GXI | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| February 21, 2020 | K192491 | Coolief Radiofrequency Generator (CRG) System | GXD | Substantially Equivalent | Avanos Medical, Inc. | accessdata.fda.gov |
| October 29, 2019 | K192114 | Game Ready GRPro 2.1 System | IRP | Substantially Equivalent | Cool Systems, Inc. (Dba Game Ready) | accessdata.fda.gov |
| March 22, 2019 | K181360 | ON-Q* Pump with Bolus | MEB | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| September 29, 2017 | K171685 | Med4 Elite | IRP | Substantially Equivalent | Cool Systems, Inc. (Dba Game Ready) | accessdata.fda.gov |
| August 29, 2017 | K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | MEA | Substantially Equivalent | Summit Medical Products, Inc. | accessdata.fda.gov |
| September 30, 2016 | K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | BSO | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| June 17, 2016 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) | PNR | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| December 2, 2014 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| November 20, 2014 | K142012 | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS | PIF | Substantially Equivalent | Corpak Medsystems | accessdata.fda.gov |
| February 3, 2014 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | MEB | Substantially Equivalent | I-Flow, LLC | accessdata.fda.gov |
| September 20, 2012 | K122373 | NEOMED ORAL/ENTERAL SYRINGE | FMF | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| September 16, 2011 | K111355 | ECHOBRIGHT | CAZ | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| January 13, 2011 | K102460 | AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH | BSO | Substantially Equivalent | Summit Medical Products, Inc. | accessdata.fda.gov |
| December 22, 2010 | K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | CAZ | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| June 24, 2010 | K093662 | ECHOBRIGHT | CAZ | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| October 24, 2008 | K082923 | PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C | CAC | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| September 25, 2008 | K081864 | PROLONG | BSP | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| April 22, 2008 | K073187 | PERIPHERAL NERVE BLOCK SUPPORT TRAY | CAZ | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| October 18, 2007 | K072050 | PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS | BSO | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| July 19, 2007 | K071745 | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE | GXI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| May 24, 2007 | K070801 | IMM HYPODERMIC NEEDLE SET | FPA | Substantially Equivalent | Innovative Medical Manufacturing Co. | accessdata.fda.gov |
| January 26, 2007 | K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | MEB | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| November 21, 2006 | K063234 | ON-Q INTRODUCERS | BSO | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| December 8, 2005 | K052221 | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | Sorenson Medical, Inc. | accessdata.fda.gov |
| November 30, 2005 | K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER | BSO | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| September 9, 2005 | K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) | MEB | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| May 17, 2005 | K050499 | PROBLOC, HN SERIES AND PROLONG, PL SERIES | BSP | Substantially Equivalent | Life-Tech, Inc. | accessdata.fda.gov |
| January 11, 2005 | K043456 | MODIFICATION TO SOAKER CATHETER | BSO | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| November 6, 2003 | K033325 | AMBIT CONTINUOUS AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | Sorenson Medical, Inc. | accessdata.fda.gov |
| March 31, 2003 | K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | LRO | Substantially Equivalent | Ballard Medical Products | accessdata.fda.gov |
| March 17, 2003 | K024190 | FENESTRATED INFUSION CATHETER | FRN | Substantially Equivalent | Promedic, Inc. | accessdata.fda.gov |
| October 23, 2000 | K002389 | BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY | GXI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| August 23, 2000 | K002434 | PALM PUMP | MEA | Substantially Equivalent | Sorenson Medical, Inc. | accessdata.fda.gov |
| July 6, 2000 | K001129 | PROLONG, MODELS PL50, PL100, PL150 | CAZ | Substantially Equivalent | Life-Tech Intl., Inc. | accessdata.fda.gov |
| March 28, 2000 | K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | BSP | Substantially Equivalent | Ballard Medical Products | accessdata.fda.gov |
| March 4, 1999 | K984502 | NERVE BLOCK INFUSION KIT | MEB | Substantially Equivalent | I-Flow Corp. | accessdata.fda.gov |
| July 17, 1998 | K972846 | BMC RF CANNULA | GXI | Substantially Equivalent | Baylis Medical Co., Inc. | accessdata.fda.gov |
| July 21, 1997 | K970178 | CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM | KNT | Substantially Equivalent | Corpak, Inc. | accessdata.fda.gov |
| July 14, 1995 | K942988 | FILTERED EXTENSION SETS | FPA | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| May 30, 1995 | K941153 | EPI-SPINAL ANESTHESIA TRAY | CAZ | Unknown | Preferred Medical Products | accessdata.fda.gov |
| February 17, 1994 | K924065 | MIC PEG TUBE | KNT | Unknown | Medical Innovations Corp. | accessdata.fda.gov |
| December 1, 1993 | K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | KNT | Unknown | Medical Innovations Corp. | accessdata.fda.gov |
| June 7, 1991 | K904440 | LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS | CAZ | Substantially Equivalent | Preferred Medical Products | accessdata.fda.gov |
| September 21, 1988 | K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE | KNT | Substantially Equivalent | Corpak Co. | accessdata.fda.gov |
| November 5, 1985 | K853253 | CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI | KNT | Substantially Equivalent | Corpak Co. | accessdata.fda.gov |
| April 4, 1984 | K840656 | ENTERNAL Y EXTENSION SET RECORDER | KNT | Substantially Equivalent | Corpak Medsystems | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Probe, Radiofrequency Lesion
- All makers of Gastrointestional Tube Holder
- All makers of General Surgery Tray
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
Updated January 31, 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.