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Data / Medical devices / Mexico / Flextronics Manufacturing Juarez S. DE R.L. DE C.V.

Flextronics Manufacturing Juarez S. DE R.L. DE C.V.: FDA-registered device maker in Juarez Chihuahua, Mexico, 12 510(k) clearances

Flextronics Manufacturing Juarez S. DE R.L. DE C.V. is registered with the FDA (registration 3007344957) in Juarez Chihuahua, Mexico. It lists 32 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 6, 2020. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Flextronics Manufacturing Juarez S. DE R.L. DE C.V.
FDA registration number
3007344957
Address
Boulevard Independencia No. 4240 Col. Lote Bravo, Juarez Chihuahua, Mexico, 32695
Owner or operator
Flextronics International USA, Inc. (9006592)
Roles
Contract manufacturer, Exporter to the US
First device listed
November 4, 2008
Registered through
2026
Brand names listed
ASSY,SHIP,CEN A .9 30BAL, Alcon Surgical Procedure Packs, B-D GUARDIAN CHEMOTHERAPY SHARPS COLLECTORS, B-D GUARDIAN NESTABLE SHARPS COLLEC, B-D GUARDIAN NESTABLE SHARPS COLLECTORS, B-D GUARDIAN ONE PIECE SHARPS COLLECTORS, B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS, BD NEEDLE,25GX7/8, BD NEEDLE,20GX1-1/2 and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, SterileKXG1Exporter to the USaccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Exporter to the USaccessdata.fda.gov
Cannula, OphthalmicHMX1Exporter to the USaccessdata.fda.gov
Container, I.V.KPE2Exporter to the USaccessdata.fda.gov
Container, SharpsMMK2Contract manufactureraccessdata.fda.gov
Continuous, Ventilator, Home UseNOU2Contract manufactureraccessdata.fda.gov
Drape, Patient, OphthalmicHMT2Exporter to the USaccessdata.fda.gov
Drape, Surgical, ExemptPUI2Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
General Surgery TrayLRO2Contract manufactureraccessdata.fda.gov
Generator, Oxygen, PortableCAW2Contract manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the USaccessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Over The CounterQUG2Exporter to the USaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the USaccessdata.fda.gov
Knife, OphthalmicHNN1Exporter to the USaccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Contract manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract manufactureraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Exporter to the USaccessdata.fda.gov
Pad, EyeHMP1Exporter to the USaccessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Over The CounterQUH2Contract manufactureraccessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, PrescriptionQDD2Contract manufactureraccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Stopcock, I.V. SetFMG2Exporter to the USaccessdata.fda.gov
Surgeon'S GlovesKGO1Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufactureraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Exporter to the USaccessdata.fda.gov
Tubing, NoninvasiveGAZ2Exporter to the USaccessdata.fda.gov
Unit, PhacofragmentationHQC2Exporter to the USaccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Contract manufactureraccessdata.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
March 6, 2020K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
June 9, 2014K140539AERO BLUE PERFORMANCE SURGICAL GOWNFYASubstantially EquivalentKimberly-Clark Corporationaccessdata.fda.gov
December 21, 2012K121555CENTURION VISION SYSTEMHQCSubstantially EquivalentAlcon Laboratories, Inc.accessdata.fda.gov
May 13, 2011K110771BD SINGLE USE, HYPODERMIC SYRINGEFMFSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
October 15, 2003K031301ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATINGKGOSubstantially EquivalentCardinalhealthaccessdata.fda.gov
August 14, 2001K011721ESTEEM STERILE POLYISOPRENE SURGICAL GLOVESKGOSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
April 14, 2000K000971PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILEKGOSubstantially EquivalentWrp Asia Pacific Sdn. Bhd.accessdata.fda.gov
June 14, 1999K991758MONOJECT INSULIN SYRINGEFMFSubstantially EquivalentThe Kendal Co.accessdata.fda.gov
June 3, 1991K911415TRUMPET VALVEFMGSubstantially EquivalentB. Braun of America, Inc.accessdata.fda.gov
May 7, 1990K901761STERILE SUCTION TUBING SETBYYSubstantially EquivalentAcacia Laboratories, Inc.accessdata.fda.gov
September 20, 1985K852893VIAL DECANTERKPESubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
April 28, 1983K831087MINI-VOL EXTENSION SETFPASubstantially EquivalentBeech Medical, Inc.accessdata.fda.gov

Compare with other makers

Updated March 6, 2020. 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.