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Data / Medical devices / Mexico / Ethicon, Inc.

Ethicon, Inc.: FDA-registered device maker in CIUDAD JUAREZ Chihuahua, Mexico, 24 510(k) clearances and 1 PMA approval

Ethicon, Inc. is registered with the FDA (registration 3006638824) in CIUDAD JUAREZ Chihuahua, Mexico. It lists 36 device types. The FDA files 24 510(k) clearances and 1 PMA approval under its listings, the newest dated May 18, 2026. 1 recall event names it as the recalling firm. 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.

Get makers like this oneWatch Ethicon, Inc.
FDA registration number
3006638824
Address
Calle Durango No. 2751 LOTE BRAVO, CIUDAD JUAREZ Chihuahua, Mexico, C.P. 32575
Owner or operator
ETHICON INC. (2210968)
Roles
Contract manufacturer, Manufacturer
First device listed
December 20, 1977
Registered through
2026
Brand names listed
1.1 MM TROCAR TIP GUIDEWIRE, 1.6MM GUIDEWIREETO, ACL ACC DISPOSABLES KIT *EA, ADJ. DISPOSABLESYSTEM, All-In-One, CHIA PERCPASSER SUTURE PASSER 5 PACK, COATED VICRYL SUTURE, Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract manufactureraccessdata.fda.gov
Applier, Staple, Surgical,GEF1Contract manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Contract manufactureraccessdata.fda.gov
Device, Occlusion, UmbilicalFOD1Manufactureraccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Contract manufactureraccessdata.fda.gov
Electrode, Pacemaker, TemporaryLDF2Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
Implant, Anti-Gastroesophageal RefluxLEI3Contract manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Needle, Cerclage, GynecologicalHDH1Manufactureraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneDXZ2Manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Contract manufactureraccessdata.fda.gov
ReamerHTO1Contract manufactureraccessdata.fda.gov
Scalpel, One-PieceGDX1Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
Staple, Fixation, BoneJDR2Contract manufactureraccessdata.fda.gov
Staple, ImplantableGDW2Manufactureraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Manufactureraccessdata.fda.gov
Suture, Absorbable, SyntheticGAN2Manufactureraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Contract manufacturer, Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGAQ2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Contract manufacturer, Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Manufactureraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Contract manufacturer, Manufactureraccessdata.fda.gov
System, Ablation, Microwave And AccessoriesNEY2Contract manufactureraccessdata.fda.gov
Tube, Smoke Removal, EndoscopicFCZ1Contract 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
May 18, 2026K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesNEWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
February 6, 2026K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
November 12, 2025K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
February 22, 2022K212380PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureNEWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
December 21, 2020K201996Monocryl Plus Antibacterial SutureGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
June 27, 2019K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
January 10, 2019K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control DevicesNEWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
September 28, 2018K181652Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable SutureGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
August 2, 2018K173923Temporary Cardiac Pacing WireLDFSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
November 1, 2017K170767Surgical Stainless Steel Suture, Stainless Steel SutureGAQSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
February 28, 2014K132580COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTUREGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
December 6, 2013K133356PROLENE POLYPROPYLENE NONABSORBABLE SUTUREGAWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
February 5, 2013K123114ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICEGDWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
April 7, 2010K093845ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25GDWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
July 14, 2006K061037PDS PLUS ANTIBACTERIAL SUTURENEWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
June 29, 2005K050845MONOCRYL PLUS ANTIBACTERIAL SUTUREGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
October 22, 2003K032420MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTUREGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
September 13, 2002K022269COATED VICRYL* (POLYGLACTIN 910) SUTUREGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
July 10, 2000K001625PRONOVA NONABSORBABLE SUTURE, USPGAWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
December 18, 1996K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDGANSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
October 25, 1996K963329ETHICON ENDOSUTURE SYSTEMGCJSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
March 28, 1996K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)GANSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
January 9, 1995K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
August 12, 1981K811872TEFLON PLEDGET SUTURE BUTTRESSDXZSubstantially EquivalentETHICON, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
January 28, 1982N18331PDS SUTURE (DYED)NEW27May 12, 1997accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
October 8, 202495583Class IIOngoingMONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophDue a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.accessdata.fda.gov

Compare with other makers

Updated May 18, 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.