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Data / Medical devices / Mexico / Bard Reynosa S.A. De C.V.

Bard Reynosa S.A. De C.V.: FDA-registered device maker in REYNOSA Tamaulipas, Mexico, 39 510(k) clearances

Bard Reynosa S.A. De C.V. is registered with the FDA (registration 9617592) in REYNOSA Tamaulipas, Mexico. It lists 48 device types. The FDA files 39 510(k) clearances under its listings, the newest dated May 13, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
9617592
FEI number
3002468371
Address
BLVD. MONTEBELLO No. 1 PARQUE INDUSTRIAL COLONIAL, REYNOSA Tamaulipas, Mexico, --
Owner or operator
C. R. Bard, Inc. (2212754)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
March 18, 1994
Registered through
2026
Brand names listed
Accessory - Foam Strips, AccuCath Ace™ Intravascular Catheter, Advance Introducer and SecureLoc Safety Introducer, Align Introducers, AllPoints™ Dressing Change Kit, Alphacurve, Atlas Gold PTA Dilatation Catheter, Atlas PTA Balloon Dilatation Catheter and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Suction, Patient CareDWM2Contract manufactureraccessdata.fda.gov
Balloon Aortic ValvuloplastyOZT2Contract manufactureraccessdata.fda.gov
Biopsy NeedleFCG2Contract manufactureraccessdata.fda.gov
Bone Marrow Collection/Transfusion KitLWE2Contract manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Contract manufactureraccessdata.fda.gov
Catheter, Angioplasty, Peripheral, TransluminalLIT2Contract manufactureraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Contract manufactureraccessdata.fda.gov
Catheter, Hemodialysis, ImplantedMSD2Contract manufactureraccessdata.fda.gov
Catheter, Hemodialysis, Non-ImplantedMPB2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Hemodialysis, Triple Lumen, Non-ImplantedNIE2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, PercutaneousDQY2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, SubclavianLFJ2Contract manufactureraccessdata.fda.gov
Catheter, Ureteral, Gastro-UrologyEYB2Contract manufactureraccessdata.fda.gov
Catheter, UrologicalKOD2Contract manufactureraccessdata.fda.gov
Central Venous Catheter With Manual Insertion SystemSEF2Contract manufactureraccessdata.fda.gov
Clamp, CannulaFKC1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Vein StabilizationLBJ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Dilator, UrethralKOE2Contract manufactureraccessdata.fda.gov
Dilator, VesselFKA2Contract manufactureraccessdata.fda.gov
Dressing Change TrayOXQ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Contract manufactureraccessdata.fda.gov
Filiform And Filiform FollowerFBW1Contract manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYURepackager or relabeleraccessdata.fda.gov
Instrument, BiopsyKNW2Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Contract manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Kit, Repair, Catheter, HemodialysisNFK2Contract manufactureraccessdata.fda.gov
Midline CatheterPND2Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Non-Coring (Huber) NeedlePTI2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term IndwellingPNG2Contract manufactureraccessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, IntravascularLJT2Contract manufactureraccessdata.fda.gov
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty CatheterOMZ2Contract manufactureraccessdata.fda.gov
Set, Administration, IntravascularFPA2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Subcutaneous Implanted Apheresis PortPTD2Contract manufactureraccessdata.fda.gov
System, Applicator, Radionuclide, ManualIWJ1Contract manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Contract manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Contract manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Thoracentesis TrayPXI2Contract manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, NeedleFSH1Contract manufactureraccessdata.fda.gov
Wire, Guide, CatheterDQX2Repackager or relabeleraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 13, 2022K213203Provena(TM) Midline CatheterPNDSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
August 8, 2017K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetPTISubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
June 1, 2015K141531POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETERNIEUnknownC.R. Bard, Inc.accessdata.fda.gov
February 20, 2015K143135Spring Coil GuidewireDQXSubstantially EquivalentNeometrics, Inc.accessdata.fda.gov
September 24, 2014K133456POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETERNIEUnknownC.R. Bard, Inc.accessdata.fda.gov
August 21, 2012K121485GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSINGQSYSubstantially EquivalentHemcon Medical Technologies Europe, Ltd.accessdata.fda.gov
July 21, 2011K102405INFUSION SET FOR POWERPICC SOLO 2 CATHETERFPASubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
November 17, 2010K102159POWERPICC SV CATHETERSLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
August 7, 2009K091324SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLETLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
February 12, 2009K090102NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERSMPBUnknownC.R. Bard, Inc.accessdata.fda.gov
October 31, 2007K072130PTFE PEEL AWAY MICROINTRODUCERDYBSubstantially EquivalentIntromedaccessdata.fda.gov
October 5, 2007K072230POWERPICC SOLOLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
May 8, 2007K0709964 FR SINGLE LUMEN (SL) POWERPICC CATHETERLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
April 4, 2007K063848POWERGROSHONG PICC CATHETERLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
November 21, 2006K063240SHERLOCK TLS STYLET, SHERLOCK TLS DETECTORLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
April 14, 2006K060341SHERLOCK TIP LOCATION SYSTEM (TLS)FOZSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
January 13, 2006K053501POWERPICCLJSSubstantially EquivalentBard Access Systems, Inc.accessdata.fda.gov
November 23, 2005K051672POWERPICCLJSSubstantially EquivalentBard Access Systems, Inc.accessdata.fda.gov
October 20, 2005K051991POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINELJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
June 15, 2005K0509316 FR DL POWERPICC CATHETERLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
May 12, 2005K050600MINILOC SAFETY INFUSION SETFPASubstantially EquivalentSpecialized Health Products, Intl.accessdata.fda.gov
February 18, 2005K050023SECURELOC; ADVANCINTRODUCERDYBSubstantially EquivalentSpecialized Health Products, Inc.accessdata.fda.gov
October 19, 2004K042445SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KITITXSubstantially EquivalentBard Access Systems, Inc.accessdata.fda.gov
March 19, 2004K033389POWERPICC CATHETERS, MODELS 3175155, 3175135LJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
January 21, 2004K034020GROSHONG NXT PICC CATHETERSLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
January 21, 2004K034019POLY PER-Q-CATH PICC CATHETERSLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
July 30, 2003K030268NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERSMPBSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
December 18, 2002K023374GROSHONG NXT DUAL LUMEN PICC CATHETERSLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
April 13, 2001K010778NIAGARA SLIM-CATHMPBSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
September 19, 2000K001901POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135LJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
January 27, 2000K993848MILLENNIUM HUBER PLUS SAFETY INFUSION SETFPASubstantially EquivalentMillennium Medical Distribution, Inc.accessdata.fda.gov
December 15, 1995K954422PER-Q-CATH MID-LINELJSSubstantially EquivalentGesco Intl., Inc.accessdata.fda.gov
November 21, 1995K954104PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICESLJSSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
March 7, 1994K9263313.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATHLJSUnknownBard Access Systems, Inc.accessdata.fda.gov
January 27, 1992K915167GESCO PER-Q-CATH CATHETER INTRODUCERDYBSubstantially EquivalentGesco Intl., Inc.accessdata.fda.gov
March 29, 1991K910622GESCO PER-Q-CATH REPAIR KITLJSUnknownGesco Intl., Inc.accessdata.fda.gov
October 22, 1990K903530PERCUTANEOUS INTRODUCERSDYBSubstantially EquivalentDavol, Inc.accessdata.fda.gov
August 12, 1987K871080PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERDQYSubstantially EquivalentCatheter Technology Corp.accessdata.fda.gov
December 18, 1986K863606BUTTERFLY NON-CORING NEEDLE SETFMISubstantially EquivalentCormed, Inc., Sub. C.R.Bard, Inc.accessdata.fda.gov

Compare with other makers

Updated May 13, 2022. 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.