EVARREST
Fibrinogen Human and Human Thrombin
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1614993 | 1614993 | ETHICON, INC. | 1 | N | 2026-01-01 | 3348 PULLIAM ST. SAN ANGELO TX US 76905 |
| 2210968 | 2210968 | ETHICON, INC. | 1 | Y | 2026-01-01 | ROUTE 22 WEST, P.O. Box 151 Somerville NJ US 08876 |
| 3006638824 | 3006638824 | ETHICON, INC. | 1 | N | 2026-01-01 | Calle Durango No. 2751 LOTE BRAVO CIUDAD JUAREZ Chihuahua MX C.P. 32575 |
| 3017102971 | 3017102971 | ETHICON, INC. | 1 | Y | 2026-01-01 | 1000 Route 202 Raritan NJ US 08869 |
| 1049223 | 1049223 | ETHICON, INC. | 1 | N | 2020-04-25 | 655 ETHICON CIRCLE CORNELIA GA US 30531 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 6246 | 1170950481 | P880047 | INTERCEED TC7 ABSORBABLE ADHESION BARRIER | MCN | 1989-09-15 |
| 284315 | 1170950481 | P880047 | INTERCEED TC7 ABSORBABLE ADHESION BARRIER | MCN | 1989-09-15 |
| 6246 | 1434504808 | P830079 | INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT | LMF | 1985-10-10 |
| 284315 | 1008974184 | P240035 | ETHIZIA | SGV | 2025-12-15 |
| 6252 | 1443909531 | N18331 | |||
| 6246 | 1443909531 | N18331 | |||
| 6247 | 1443909531 | N18331 | |||
| 284315 | 1443909531 | N18331 | |||
| 6246 | 1473257636 | N12159 | SURGICEL BRAND ABSORBABLE HEMOSTAT | LMG | 1960-10-14 |
| 284315 | 1473257636 | N12159 | SURGICEL BRAND ABSORBABLE HEMOSTAT | LMG | 1960-10-14 |
| 6246 | 2040247741 | K984220 | MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH | FTL | 1999-02-23 |
| 284315 | 2040247741 | K984220 | MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH | FTL | 1999-02-23 |
| 6246 | 1882483136 | K980503 | TEMPORARY CARDIAC PACING WIRE | LDF | 1998-04-10 |
| 6246 | 1638534394 | K972426 | MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH | HIH | 1997-09-23 |
| 6252 | 1558018805 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | 1996-12-18 |
| 6246 | 1558018805 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | 1996-12-18 |
| 6247 | 1558018805 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | 1996-12-18 |
| 284315 | 1558018805 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | 1996-12-18 |
| 6246 | 1353127546 | K963329 | ETHICON ENDOSUTURE SYSTEM | GCJ | 1996-10-25 |
| 6252 | 1353127546 | K963329 | ETHICON ENDOSUTURE SYSTEM | GCJ | 1996-10-25 |
| 284315 | 1353127546 | K963329 | ETHICON ENDOSUTURE SYSTEM | GCJ | 1996-10-25 |
| 6252 | 1592490496 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | 1996-03-28 |
| 6246 | 1592490496 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | 1996-03-28 |
| 6247 | 1592490496 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | 1996-03-28 |
| 284315 | 1592490496 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | 1996-03-28 |
| 6246 | 1518617461 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | 1995-01-09 |
| 6252 | 1518617461 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | 1995-01-09 |
| 284315 | 1518617461 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | 1995-01-09 |
| 6247 | 1081087910 | K931492 | LAPRA-TY* SUTURE CLIP | FZP | 1993-08-24 |
| 6246 | 1081087910 | K931492 | LAPRA-TY* SUTURE CLIP | FZP | 1993-08-24 |
| 284315 | 1081087910 | K931492 | LAPRA-TY* SUTURE CLIP | FZP | 1993-08-24 |
| 6246 | 1691224521 | K931271 | ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE | GAQ | 1994-01-07 |
| 284315 | 1691224521 | K931271 | ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE | GAQ | 1994-01-07 |
| 6246 | 1369145307 | K925914 | PRE-TIED LOOP SUTURE CANNULA | GCJ | 1993-05-12 |
| 6246 | 1063365647 | K843187 | CANNULA | GEA | 1984-10-31 |
| 284315 | 1063365647 | K843187 | CANNULA | GEA | 1984-10-31 |
| 6246 | 1247486377 | K812819 | ETHICON* SURGICAL SUTURES W/COMPRESS BOL | KGS | 1981-11-20 |
| 6246 | 1115917421 | K811872 | TEFLON PLEDGET SUTURE BUTTRESS | DXZ | 1981-08-12 |
| 6252 | 1115917421 | K811872 | TEFLON PLEDGET SUTURE BUTTRESS | DXZ | 1981-08-12 |
| 284315 | 1115917421 | K811872 | TEFLON PLEDGET SUTURE BUTTRESS | DXZ | 1981-08-12 |
| 6246 | 1787432592 | K810428 | VICRYL | FTL | 1981-03-13 |
| 6247 | 1787432592 | K810428 | VICRYL | FTL | 1981-03-13 |
| 284315 | 1787432592 | K810428 | VICRYL | FTL | 1981-03-13 |
| 284315 | 1358849286 | K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | GAM | 2026-02-06 |
| 6247 | 1358849286 | K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | GAM | 2026-02-06 |
| 6252 | 1358849286 | K253852 | MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | GAM | 2026-02-06 |
| 284315 | 2007747037 | K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device | GAW | 2026-03-27 |
| 6247 | 1396753773 | K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2025-12-22 |
| 284315 | 1396753773 | K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2025-12-22 |
| 284315 | 1239748627 | K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | NEW | 2026-05-18 |
| 6247 | 1239748627 | K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | NEW | 2026-05-18 |
| 6252 | 1239748627 | K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | NEW | 2026-05-18 |
| 284315 | 1290325454 | K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | NEW | 2025-11-12 |
| 6252 | 1290325454 | K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | NEW | 2025-11-12 |
| 6247 | 1290325454 | K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | NEW | 2025-11-12 |
| 284315 | 1361677685 | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2022-11-15 |
| 6247 | 1361677685 | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2022-11-15 |
| 6246 | 1361677685 | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | GAM | 2022-11-15 |
| 6246 | 1144828700 | K213512 | DERMABOND PRINEO Skin Closure System | OMD | 2021-12-07 |
| 284315 | 1144828700 | K213512 | DERMABOND PRINEO Skin Closure System | OMD | 2021-12-07 |
| 6246 | 1241592231 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | 2022-02-22 |
| 284315 | 1241592231 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | 2022-02-22 |
| 6247 | 1241592231 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | 2022-02-22 |
| 6252 | 1241592231 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | NEW | 2022-02-22 |
| 6252 | 1194437799 | K201996 | Monocryl Plus Antibacterial Suture | GAM | 2020-12-21 |
| 6246 | 1194437799 | K201996 | Monocryl Plus Antibacterial Suture | GAM | 2020-12-21 |
| 6247 | 1194437799 | K201996 | Monocryl Plus Antibacterial Suture | GAM | 2020-12-21 |
| 284315 | 1194437799 | K201996 | Monocryl Plus Antibacterial Suture | GAM | 2020-12-21 |
| 6247 | 2028986319 | K201143 | VICRYL Mesh | FTL | 2020-08-06 |
| 6246 | 2028986319 | K201143 | VICRYL Mesh | FTL | 2020-08-06 |
| 284315 | 2028986319 | K201143 | VICRYL Mesh | FTL | 2020-08-06 |
| 6247 | 1037058608 | K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | GAM | 2019-12-18 |
| 284315 | 1037058608 | K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | GAM | 2019-12-18 |
| 6246 | 1037058608 | K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | GAM | 2019-12-18 |
| 6247 | 2002997201 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | NEW | 2020-03-25 |
| 6246 | 2002997201 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | NEW | 2020-03-25 |
| 284315 | 2002997201 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | NEW | 2020-03-25 |
| 6247 | 1465268838 | K191373 | VICRYL Mesh | FTL | 2019-10-22 |
| 6246 | 1465268838 | K191373 | VICRYL Mesh | FTL | 2019-10-22 |
| 284315 | 1465268838 | K191373 | VICRYL Mesh | FTL | 2019-10-22 |
| 6252 | 2024215446 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | 2019-06-27 |
| 6247 | 2024215446 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | 2019-06-27 |
| 6246 | 2024215446 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | 2019-06-27 |
| 284315 | 2024215446 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | 2019-06-27 |
| 6252 | 2069495598 | K182873 | STRATAFIX 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 Devices | NEW | 2019-01-10 |
| 6246 | 2069495598 | K182873 | STRATAFIX 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 Devices | NEW | 2019-01-10 |
| 6247 | 2069495598 | K182873 | STRATAFIX 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 Devices | NEW | 2019-01-10 |
| 284315 | 2069495598 | K182873 | STRATAFIX 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 Devices | NEW | 2019-01-10 |
| 6247 | 1347253557 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | 2018-09-28 |
| 6252 | 1347253557 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | 2018-09-28 |
| 6246 | 1347253557 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | 2018-09-28 |
| 284315 | 1347253557 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | 2018-09-28 |
| 6246 | 1413462888 | K181268 | PROLENE (Polypropylene) 3D Patch | FTL | 2018-07-26 |
| 284315 | 1413462888 | K181268 | PROLENE (Polypropylene) 3D Patch | FTL | 2018-07-26 |
| 6246 | 1530004738 | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | PWJ | 2018-08-10 |
| 6246 | 1475918027 | K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | FTL | 2018-07-02 |
| 284315 | 1475918027 | K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | FTL | 2018-07-02 |
| 6246 | 1196357990 | K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | FTL | 2018-06-28 |
| 284315 | 1196357990 | K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | FTL | 2018-06-28 |
| 6246 | 1515364312 | K173923 | Temporary Cardiac Pacing Wire | LDF | 2018-08-02 |
| 284315 | 1515364312 | K173923 | Temporary Cardiac Pacing Wire | LDF | 2018-08-02 |
| 6252 | 1515364312 | K173923 | Temporary Cardiac Pacing Wire | LDF | 2018-08-02 |
| 6246 | 1653168984 | K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | PWJ | 2018-06-28 |
| 6246 | 1790870716 | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | PWJ | 2018-07-06 |
| 6246 | 1553665521 | K172089 | PROLENE Soft Polypropylene Mesh | FTL | 2017-10-05 |
| 284315 | 1553665521 | K172089 | PROLENE Soft Polypropylene Mesh | FTL | 2017-10-05 |
| 6246 | 1865853369 | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | GAQ | 2017-11-01 |
| 6252 | 1865853369 | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | GAQ | 2017-11-01 |
| 284315 | 1865853369 | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | GAQ | 2017-11-01 |
| 6246 | 1557446161 | K163645 | DERMABOND PRINEO Skin Closure System | OMD | 2017-04-21 |
| 284315 | 1557446161 | K163645 | DERMABOND PRINEO Skin Closure System | OMD | 2017-04-21 |
| 6246 | 1386138205 | K152490 | DERMABOND PRINEO Skin Closure System | OMD | 2015-11-25 |
| 284315 | 1386138205 | K152490 | DERMABOND PRINEO Skin Closure System | OMD | 2015-11-25 |
| 6246 | 1103618032 | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive | MPN | 2015-10-22 |
| 284315 | 1103618032 | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive | MPN | 2015-10-22 |
| 6246 | 1818605693 | K141560 | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE | FTL | 2014-10-23 |
| 284315 | 1818605693 | K141560 | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE | FTL | 2014-10-23 |
| 6252 | 1666191165 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | 2013-12-06 |
| 6246 | 1666191165 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | 2013-12-06 |
| 284315 | 1666191165 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | 2013-12-06 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GAM | 41 | 2026-02-06 |
| FTL | 28 | 2020-08-06 |
| NEW | 21 | 2026-05-18 |
| GAQ | 8 | 2017-11-01 |
| GAN | 8 | 1996-12-18 |
| GAW | 7 | 2026-03-27 |
| OMD | 6 | 2021-12-07 |
| GDW | 6 | 2013-02-05 |
| GCJ | 6 | 2005-08-09 |
| DXZ | 5 | 2000-11-07 |
| LDF | 4 | 2018-08-02 |
| OTN | 4 | 2013-08-23 |
| OTO | 4 | 2012-06-11 |
| PWJ | 3 | 2018-08-10 |
| FZP | 3 | 1993-08-24 |
| MPN | 2 | 2015-10-22 |
| NHB | 2 | 2010-02-17 |
| MCN | 2 | 1989-09-15 |
| GEA | 2 | 1984-10-31 |
| LMG | 2 | 1960-10-14 |
| PAH | 1 | 2005-11-28 |
| HIH | 1 | 1997-09-23 |
| LMF | 1 | 1985-10-10 |
| KGS | 1 | 1981-11-20 |
Fibrinogen Human and Human Thrombin
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, Inc.
ETHICON, Inc.
ETHICON, Inc.
ETHICON, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
Ethicon, Inc.
ETHICON, INC.
ETHICON, INC.
Ethicon, Inc.
ETHICON, INC.
ETHICON, INC.
ETHICON, Inc.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.
ETHICON, INC.