FDA.reportPublic FDA data

ETHICON, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26486502648650ETHICON, LLC.1N2026-01-01Highway 183 Km. 8.3 San Lorenzo PR US 00754

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
62491170950481P880047INTERCEED TC7 ABSORBABLE ADHESION BARRIERMCN1989-09-15
62491473257636N12159SURGICEL BRAND ABSORBABLE HEMOSTATLMG1960-10-14
62491882483136K980503TEMPORARY CARDIAC PACING WIRELDF1998-04-10
62491518617461K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
62491396753773K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceGAM2025-12-22
62491361677685K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceGAM2022-11-15
62491144828700K213512DERMABOND PRINEO Skin Closure SystemOMD2021-12-07
62491037058608K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceGAM2019-12-18
62492002997201K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceNEW2020-03-25
62492069495598K182873STRATAFIX 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 DevicesNEW2019-01-10
62491196357990K180829PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical MeshFTL2018-06-28
62491515364312K173923Temporary Cardiac Pacing WireLDF2018-08-02
62491553665521K172089PROLENE Soft Polypropylene MeshFTL2017-10-05
62491865853369K170767Surgical Stainless Steel Suture, Stainless Steel SutureGAQ2017-11-01
62491557446161K163645DERMABOND PRINEO Skin Closure SystemOMD2017-04-21
62491386138205K152490DERMABOND PRINEO Skin Closure SystemOMD2015-11-25
62491103618032K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin AdhesiveMPN2015-10-22
62491666191165K133356PROLENE POLYPROPYLENE NONABSORBABLE SUTUREGAW2013-12-06
62491501242799K013718GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIROTO2002-01-08
62491705273878K003070ETHIBOND EXCEL VALVE LOOP SUTUREDXZ2000-11-07
62491375117409K001625PRONOVA NONABSORBABLE SUTURE, USPGAW2000-07-10
62491055796924
62491641922363
62492036247697

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GAM32025-12-22
OMD32021-12-07
NEW22020-03-25
LDF22018-08-02
FTL22018-06-28
GAQ22017-11-01
GAW22013-12-06
MPN12015-10-22
OTO12002-01-08
DXZ12000-11-07
MCN11989-09-15
LMG11960-10-14