Data / Medical devices / Mexico / Teleflex Medical de Tecate, S. de R.L de C.V.
Teleflex Medical de Tecate, S. de R.L de C.V.: FDA-registered device maker in TECATE Baja California, Mexico, 101 510(k) clearances and 1 PMA approval
Teleflex Medical de Tecate, S. de R.L de C.V. is registered with the FDA (registration 3003898360) in TECATE Baja California, Mexico. It lists 72 device types. The FDA files 101 510(k) clearances and 1 PMA approval under its listings, the newest dated July 3, 2025. Registered through 2026. 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
- 3003898360
- Address
- (A Teleflex Medical Company) Prolongacion Mision Eusebio Kino No. 1316,Rancho El Descanso, TECATE Baja California, Mexico, C.P. 21478
- Owner or operator
- Teleflex (9062981)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- September 29, 1995
- Registered through
- 2026
- Brand names listed
- ADAPT LAPAROSCOPIC, ADAPT UNIVERSAL LAPAROSCOPIC PORT,, ATOMIZER, AVA NEB NEBULIZER, Accumed Wrist Splint. Model Numbers 3565-Accumed PWPS and 3560-Accumed II, Flat, Airway Lifesaver Kit, Anesthesia Circuit, Aquapak 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. Newest 100 of 101.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 3, 2025 | K251054 | Hem-o-lok PurplePlus Large Polymer Ligating Clips | FZP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| March 18, 2025 | K243553 | QuikClot Control+ Hemostatic Device | POD | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| May 31, 2024 | K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | LOX | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| January 12, 2024 | K232970 | Hem-o-lok® Ligating Clips | FZP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| October 6, 2023 | K231603 | Standard Staple-Line Reinforcement (SSLR23) | OXC | Substantially Equivalent | Standard Bariatrics, Inc. | accessdata.fda.gov |
| September 22, 2023 | K232558 | UroLift 2 ATC Advanced Tissue Control System | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| April 28, 2023 | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | FZP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| December 14, 2022 | K220971 | QuikClot Control+ Hemostatic Dressing | POD | Substantially Equivalent | Z-Medica, LLC | accessdata.fda.gov |
| August 22, 2022 | K220363 | VPS Rhythm DLX Device with TipTracker Technology | LJS | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| August 18, 2022 | K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| June 17, 2022 | K221470 | Langston dual lumen catheter | DQO | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| April 30, 2021 | K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| July 31, 2020 | K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| June 5, 2020 | K200441 | UroLift Advanced Tissue Control (ATC) System | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| December 20, 2019 | K193269 | UroLift System (UL400) | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| August 9, 2019 | K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | DQY | Substantially Equivalent | Vascular Solutions, LLC | accessdata.fda.gov |
| December 24, 2018 | K181641 | QuikClot Radial | QSY | Substantially Equivalent | Z-Medica, LLC | accessdata.fda.gov |
| November 2, 2018 | K180253 | Sheridan Endobronchial Tubes | CBI | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| October 12, 2018 | K181852 | Percuvance Percutaneous Surgical System | GEI | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| October 20, 2017 | K172090 | GuideLiner V3 Catheter | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| June 30, 2017 | DEN160012 | D2 Dressing | POD | Unknown | Z-Medica, LLC | accessdata.fda.gov |
| February 3, 2017 | K161901 | TrapLiner catheter | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| December 22, 2016 | K160925 | VPS Rhythm Device with TipTracker Technology | LJS | Substantially Equivalent | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| August 19, 2016 | K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | CCT | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| April 8, 2016 | K153063 | PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM | GEI | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| February 4, 2016 | K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | LJS | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| January 21, 2015 | K143299 | Percuvance(R) Percutaneous Surgical System | GCJ | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| December 19, 2014 | K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier | FZP | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| November 24, 2014 | K141939 | TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET | BTR | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| October 30, 2014 | K142138 | ISO-GARD MASK | CBN | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| March 6, 2014 | K131912 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN | BTT | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| December 3, 2013 | K133202 | HEM-O-LOK LIGATING CLIP | FZP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| November 27, 2013 | K132658 | HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS | FZP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| April 12, 2013 | K123387 | QUIKCLOT HEMOSTATIC DRESSING | QSY | Substantially Equivalent | Z-Medica, LLC | accessdata.fda.gov |
| March 20, 2013 | K120782 | INTERVENTIONAL HEMOSTATIC BANDAGE | QSY | Substantially Equivalent | Z-Medica Corporation | accessdata.fda.gov |
| May 25, 2012 | K121380 | WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT | GCJ | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| October 4, 2011 | K112456 | ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT | GCJ | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| February 18, 2011 | K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | OBJ | Substantially Equivalent | Vasonova, Inc. | accessdata.fda.gov |
| December 22, 2010 | K103405 | PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH | QEZ | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| December 16, 2010 | K101659 | SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 | DQY | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| October 29, 2009 | K091761 | TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT | BTR | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| April 30, 2009 | K090300 | MODIFICATION TO AUTOFUSER | MEB | Substantially Equivalent | Ace Medical Us, LLC | accessdata.fda.gov |
| April 8, 2009 | K090620 | QUIKCLOT INTEVENTIONAL, MODEL P/N 182 | QSY | Substantially Equivalent | Z-Medica Corporation | accessdata.fda.gov |
| September 10, 2008 | K082156 | ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 | GCJ | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| October 16, 2007 | K072474 | QUIKCLOT EX | QSY | Substantially Equivalent | Z-Medica Corporation | accessdata.fda.gov |
| November 2, 2006 | K062914 | HEM-O-LOK LIGATION CLIP | FZP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| January 7, 2005 | K043205 | RUSCH EASY TUBE | BTR | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| June 17, 2003 | K023666 | RUSCH GUIDED CHOLANGIOGRAPHY CATHETER | FGE | Substantially Equivalent | Rusch Intl. | accessdata.fda.gov |
| February 26, 2003 | K030311 | HEM-O-LOK XL CLIP | FZP | Substantially Equivalent | Weck | accessdata.fda.gov |
| December 13, 2002 | K023261 | ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 | GCJ | Substantially Equivalent | Taut, Inc. | accessdata.fda.gov |
| August 14, 2002 | K021808 | WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER | FZP | Substantially Equivalent | Weck | accessdata.fda.gov |
| August 8, 2002 | K021731 | ADAPT OPEN ACCESS PORT, MODEL 41233 | GCJ | Substantially Equivalent | Taut, Inc. | accessdata.fda.gov |
| August 22, 2001 | K011811 | MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE | DXT | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| June 22, 2001 | K011018 | TAUT BALLOON CATHETER, MODEL 50640 | GCA | Substantially Equivalent | Taut, Inc. | accessdata.fda.gov |
| February 22, 2001 | K010007 | ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP | GCJ | Substantially Equivalent | Taut, Inc. | accessdata.fda.gov |
| February 22, 2001 | K003703 | TAUT-INSUFFLATION NEEDLE | HIF | Substantially Equivalent | Taut, Inc. | accessdata.fda.gov |
| December 21, 2000 | K003337 | HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 | FZP | Substantially Equivalent | Weck Closure Systems | accessdata.fda.gov |
| March 24, 2000 | K993191 | TFX MEDICAL INTRODUCER ASSEMBLY | DYB | Substantially Equivalent | Tfx Medical, Inc. | accessdata.fda.gov |
| February 4, 2000 | K991580 | ILM ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | The Laryngeal Mask Co., Ltd. | accessdata.fda.gov |
| December 17, 1999 | K993157 | HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 | FZP | Substantially Equivalent | Weck Closure Systems | accessdata.fda.gov |
| August 3, 1999 | K990619 | RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE | BTR | Substantially Equivalent | Rusch Intl. | accessdata.fda.gov |
| August 10, 1998 | K982313 | HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS | FZP | Substantially Equivalent | Weck Closure Systems | accessdata.fda.gov |
| April 15, 1997 | K964382 | HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) | CAH | Substantially Equivalent | Gibeck, Inc. | accessdata.fda.gov |
| February 21, 1997 | K964719 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Hudson Respiratory Care, Inc. | accessdata.fda.gov |
| September 10, 1996 | K961150 | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA | CCK | Substantially Equivalent | Hudson Respiratory Care, Inc. | accessdata.fda.gov |
| August 16, 1996 | K961837 | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY | BTR | Substantially Equivalent | Rusch Intl. | accessdata.fda.gov |
| July 31, 1996 | K961977 | KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE | CBI | Substantially Equivalent | Kendall Healthcare Products Co. Div.Of Tyco Health | accessdata.fda.gov |
| June 27, 1996 | K961840 | RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY | BTR | Substantially Equivalent | Rusch Intl. | accessdata.fda.gov |
| June 27, 1996 | K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | BTR | Substantially Equivalent | Rusch, Inc. | accessdata.fda.gov |
| March 20, 1996 | K960883 | INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 | GCJ | Substantially Equivalent | Taut, Inc. | accessdata.fda.gov |
| November 27, 1995 | K953963 | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION | BTS | Substantially Equivalent | Rusch, Inc. | accessdata.fda.gov |
| June 8, 1995 | K951091 | RUSCH ENDOBRONCHIAL TUBE SETS | BTS | Substantially Equivalent | Rusch Intl. | accessdata.fda.gov |
| November 7, 1994 | K944552 | PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP | FZP | Substantially Equivalent | Pilling Weck, Inc. | accessdata.fda.gov |
| October 18, 1994 | K923946 | CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER | BTT | Substantially Equivalent | Hudson Respiratory Care, Inc. | accessdata.fda.gov |
| June 23, 1993 | K931164 | RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY | BTR | Substantially Equivalent | Rusch, Inc. | accessdata.fda.gov |
| May 7, 1993 | K922894 | LAZER-TRACH TRACHEAL TUBE | BTR | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| December 17, 1992 | K925559 | BILIARY STONE DISLODGER | LQR | Substantially Equivalent | Annex Medical, Inc. | accessdata.fda.gov |
| October 21, 1991 | K911260 | ATRAUMATIC STANDARD SPROTTE NEEDLE | BSP | Substantially Equivalent | Pajunk GmbH | accessdata.fda.gov |
| June 5, 1990 | K901303 | HORIZON SURGICAL LIGATING AND MARKING CLIP | DSS | Substantially Equivalent | Horizon Surgical, Inc. | accessdata.fda.gov |
| March 23, 1990 | K897046 | LASER RESISTANT TRACHEAL TUBE | CBI | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| November 21, 1988 | K884150 | MODIFIED CONCHATHERM III CONTROLLED HEATER | BTT | Substantially Equivalent | Respiratory Care, Inc. | accessdata.fda.gov |
| April 21, 1988 | K881413 | ELECTRO-CAUTERY SUCTION TUBE | GEI | Substantially Equivalent | Alto Development Corp. | accessdata.fda.gov |
| July 11, 1986 | K862347 | ENDOTRACHEAL TUBE, ACCESSORY | BTR | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| May 6, 1986 | K861454 | END TIDAL CO2 TUBE | BTR | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| March 4, 1986 | K860105 | SPIRAL-FLEX | BTR | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| January 27, 1986 | K860176 | LARYNGECTOMY TUBE, CUFFED | BTO | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| May 23, 1985 | K851856 | TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE | CBI | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| December 4, 1984 | K844296 | TRACHEAL TUBE, REINFORCED, CUFFED | BTR | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| September 10, 1984 | K842866 | URETHRAL CATHETERIZATION TRAY | KOD | Substantially Equivalent | Inmed Corp. | accessdata.fda.gov |
| August 14, 1984 | K841549 | HEMOCLIP AUTOMATIC CLIPS MEDIUM | FZP | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
| August 14, 1984 | K841548 | HEMOCLIP LIGATING CLIPS M/LARGE | FZP | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
| August 14, 1984 | K841547 | HEMOCLIP LIGATING CLIPS MED/SML | FZP | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
| April 2, 1984 | K840565 | MONITOR 5590- ANALYZER 5595EC | CCL | Substantially Equivalent | Hudson Oxygen Therapy Sales Co. | accessdata.fda.gov |
| March 7, 1984 | K832363 | FOLEY CATHETERIZATION TRAY-VARIOUS | KOD | Substantially Equivalent | Inmed Corp. | accessdata.fda.gov |
| February 27, 1984 | K840202 | EPIDURAL CATHETER | BSO | Substantially Equivalent | Aries Medical, Inc. | accessdata.fda.gov |
| January 13, 1984 | K834151 | CONCHATHERM LHF HUMIDIFIER HEATER | BTT | Substantially Equivalent | Respiratory Care, Inc. | accessdata.fda.gov |
| January 26, 1983 | K823755 | BICEPS ELECTROCAUTERY SYSTEM | HAM | Substantially Equivalent | Squibb Diagnostics | accessdata.fda.gov |
| August 10, 1982 | K822082 | SHERIDAN/HVT,CF, UNCUFFED | BTR | Substantially Equivalent | Sheridan Catheter Corp. | accessdata.fda.gov |
| January 28, 1980 | K800079 | HEMOCLIP SURGICAL OCCLUDING CLIP | FZP | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
| December 13, 1977 | K772217 | TEMPERATURE MONITOR | FLL | Substantially Equivalent | Hudson Oxygen Therapy Sales Co. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 1, 2019 | P180025 | MANTA Vascular Closure Device | MGB | 14 | April 23, 2026 | accessdata.fda.gov |
Compare with other makers
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- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Clip, Scalp
Updated April 23, 2026. 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.