Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007344957

FEI Number

3007344957

Entity Name

Flextronics Manufacturing Juarez S. DE R.L. DE C.V.

City/State/Country

Juarez Chihuahua, MX

Establishment Address

Boulevard Independencia No. 4240, Col. Lote Bravo, Juarez Chihuahua 32695, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Flextronics International USA, Inc. (Owner Number: 9006592)

Owner / Operator Contact Address

12455 Research Blvd, Austin, TX 78759, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DRESSING,TRANSPARENT 5 1/2 X 4, APPLICATOR,COTTON TIP,WOOD,3" B-D GUARDIAN CHEMOTHERAPY SHARPS COLLECTORS BD Recyleen Sharps Collectors CANNULA,VISCO INJ,30G, CANNULA,ANT CHAMBER,27G,8MM, CANNULA,HYDRODISS,27G,FLAT EN SPONGE,KERLIX,ROLL,4.5X147 SPONGE,TONSIL,LARGE,1" SPONGE,GAUZE,4PLY,4X4 SPONGE,NUGAUZE,4PLY,3X3 SPONGE,GAUZE,8PLY,2X2 SPONGE,LAP,12X12,PREWASHED SPONGE,KERLIX,6X6.75 DECANTER,VIAL Innospire Go Direct Patient Interface SPONGE,TONSIL,XLARGE, SPONGE,GAUZE,FLUFF,LARGE SET,EXTENSION,48",M:L/L,F:L/L DRAPE,OPH,INCISE,40X48,W/PCH COVER,BACKTABLE,44"X75",SMS,EM STOPCOCK, 1-WAY tray, surgical, instrument - TRAYS AND RACKS.; VARIOUS TYPES OF CASES 10 Tray, Sugical instrument, Matrixrib Compact, MiniModule, Vario Case, Vario Tray, Zip Fix SYRINGE,1CC,TB W/25GX5/8. Jabra Enhance Select 50R Millenium M10 Alcon Surgical Procedure Packs Enhance Plus SHIELD,EYE,PLST CLEAR,W/O GRTR GN Hearing B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS Everflo - L4 OXYGEN CONCENTRATOR VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER I-NEB TIM/General Purpose SYRINGE,1CC,TB W/26GX3/8 GLOVES,SURG,8,SENSICARE,PF GLOVES,SURG,6.5,SENSICARE,PF GOWN,AEROBLUE XLRG,NS GOWN,AEROBLUE LARGE,NS KNIFE,CLEARCUT,HP2,SLIT,2.8MM KNIFE,SATINCRESCENT,STRAIGHT KNIFE,15',ANG,STRT,SIDEPORT,SA KNIFE,SLIT,2.2MM,XSTAR,SAF,ANG B-D GUARDIAN NESTABLE SHARPS COLLECTORS I-Neb AAD Nebulizer w/Insight SW or Components ASSY,SHIP,CEN A .9 30BAL SensiCare Sterile Power-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Trilogy EVO, O2, International, Trilogy EVO International, EV300 International w/OBM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2019-01-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-01-25
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2012-07-17
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-01-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-10-12
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2019-01-12
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2020-10-22
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2019-01-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-01-11
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2018-10-12
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2018-10-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-07-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-01-11
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-08-08
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2019-06-21
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2018-04-13
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2022-12-01
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2018-10-12
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Ear, Nose, Throat	Class 2	874.3325	2022-12-06
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2022-12-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-01-25
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2019-02-18
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2015-01-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2019-07-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-01-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2018-10-12
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-10-12
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-10-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-01-25
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2019-07-18
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2018-10-12
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2026-04-22
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-06-09
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2020-06-09

Official Correspondent

Chad Ashton

US Agent Details

Chad Ashton Business: FLEXTRONICS INTERNATIONAL USA, INC. Email: chad.ashton@flex.com Phone: (901) 8712423

Related Public Records

Same Entity

Flextronics International USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003027964	Flex Precision Plastics Solutions (Switzerland) AG	Hagglingen Aargau, CH
3008886285	Flextronics International Kft	Budapest, HU
3006126537	FLEXTRONICS INTERNATIONAL GMBH	ALTHOFEN Karnten, AT
3021010223	Flex Precision Plastics Solutions AG	Kussnacht Schwyz, CH
3022473387	Flextronics Medical Molding (Shenzhen) Co., Ltd	Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Similar Registrations

Registration Number	Establishment Name	Location
3032760064	CARAN PRECISION ENGINEERING & MANUFACTURING CORP.	Brea, CA, US
3015505238	CITOTEST SCIENTIFIC CO.,LTD.	Nanjing Jiangsu, CN
3014159736	VIETNAM MEDICAL PLASTIC JSC	Tam Diep Ward Ninh Binh, VN
3009656988	STERIPACK USA (LIMITED) LLC	Lakeland, FL, US
3010407203	Sterigenics Italy SpA	Minerbio Bologna, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007344957. Last updated year: 2026. Please use registration number 3007344957 when referencing this establishment in official correspondence.