FDA.report

ETHICON ENDO-SURGERY, INC.

Matched from indexed company URL: ETHICON, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
15277361527736ETHICON ENDO-SURGERY, INC.1N2026-01-014545 CREEK RD. Cincinnati OH US 45242
16149931614993ETHICON, INC.1N2026-01-013348 PULLIAM ST. SAN ANGELO TX US 76905
22109682210968ETHICON, INC.1Y2026-01-01ROUTE 22 WEST, P.O. Box 151 Somerville NJ US 08876
26486502648650ETHICON, LLC.1N2026-01-01Highway 183 Km. 8.3 San Lorenzo PR US 00754
30050758533005075853ETHICON ENDO-SURGERY, LLC1Y2026-01-01475 CALLE C GUAYNABO PR US 00969
30066388243006638824ETHICON, INC.1N2026-01-01Calle Durango No. 2751 LOTE BRAVO CIUDAD JUAREZ Chihuahua MX C.P. 32575
30077915993007791599ETHICON, LLC1Y2026-01-01475 C Street Los Frailes Industrial Park, Suite 401 Guaynabo PR US 00969
30171029713017102971ETHICON, INC.1Y2026-01-011000 Route 202 Raritan NJ US 08869
30325437533032543753Ethicon LLC1N2026-01-01PR-2, Km 45.6 Alts de Manati PR US 00674
10492231049223ETHICON, INC.1N2020-04-25655 ETHICON CIRCLE CORNELIA GA US 30531
16288081628808ETHICON ENDO-SURGERY, INC.1N2020-04-253801 University Blvd SE ALBUQUERQUE NM US 87106
96815303003131758ETHICON ENDO-SURGERY S.A. DE C.V.1N2020-04-25AVENIDA DE LAS TORRES No. 7125 COLONIA SALVARCAR 118 CIUDAD JUAREZ Chihuahua MX --32580

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
30705031045600PROLENE - Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture+1(877)384-4266xxx@xxx.xxx
30705031049097PRONOVA - Blue Monofilament Poly(Hexafluoropropylene-VDF), Nonabsorbable Surgical Suture+1(877)384-4266xxx@xxx.xxx
30705031049103PRONOVA - Blue Monofilament Poly(Hexafluoropropylene-VDF), Nonabsorbable Surgical Suture+1(877)384-4266xxx@xxx.xxx
30705031049172PRONOVA - Blue Monofilament Poly(Hexafluoropropylene-VDF), Nonabsorbable Surgical Suture+1(877)384-4266xxx@xxx.xxx

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
62461170950481P880047INTERCEED TC7 ABSORBABLE ADHESION BARRIERMCN1989-09-15
62491170950481P880047INTERCEED TC7 ABSORBABLE ADHESION BARRIERMCN1989-09-15
2843151170950481P880047INTERCEED TC7 ABSORBABLE ADHESION BARRIERMCN1989-09-15
62461434504808P830079INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTATLMF1985-10-10
2843151008974184P240035ETHIZIASGV2025-12-15
1052121015088466N18331
62461443909531N18331
62471443909531N18331
62521443909531N18331
2843151443909531N18331
62461473257636N12159SURGICEL BRAND ABSORBABLE HEMOSTATLMG1960-10-14
62491473257636N12159SURGICEL BRAND ABSORBABLE HEMOSTATLMG1960-10-14
2843151473257636N12159SURGICEL BRAND ABSORBABLE HEMOSTATLMG1960-10-14
238891055732762K990362INSTRUMENT, ULTRASONIC, SCALPELGEI1999-09-17
148921102393790K990362INSTRUMENT, ULTRASONIC, SCALPELGEI1999-09-17
148931102393790K990362INSTRUMENT, ULTRASONIC, SCALPELGEI1999-09-17
238891170899254K984240ENDOPATH ENDOSCOPIC INSTRUMENTSGEI1999-06-22
148921554236862K984240ENDOPATH ENDOSCOPIC INSTRUMENTSGEI1999-06-22
148931554236862K984240ENDOPATH ENDOSCOPIC INSTRUMENTSGEI1999-06-22
62462040247741K984220MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESHFTL1999-02-23
2843152040247741K984220MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESHFTL1999-02-23
148921520060452K983925ENDOPATH ULTRA VERESS NEEDLEHIF1999-02-03
148931520060452K983925ENDOPATH ULTRA VERESS NEEDLEHIF1999-02-03
238891986348816K983925ENDOPATH ULTRA VERESS NEEDLEHIF1999-02-03
238891191399048K983536PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERSGDW1998-12-18
148921834736525K983536PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERSGDW1998-12-18
148931834736525K983536PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERSGDW1998-12-18
148941834736525K983536PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERSGDW1998-12-18
62461882483136K980503TEMPORARY CARDIAC PACING WIRELDF1998-04-10
62491882483136K980503TEMPORARY CARDIAC PACING WIRELDF1998-04-10
148921148078054K972679ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)GCJ1997-09-19
148931148078054K972679ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)GCJ1997-09-19
238891871324409K972679ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)GCJ1997-09-19
148921177778175K972578ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVEGCJ1997-10-01
148931177778175K972578ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVEGCJ1997-10-01
238891201576253K972578ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVEGCJ1997-10-01
62461638534394K972426MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATHHIH1997-09-23
1052121132005458K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDGAN1996-12-18
62461558018805K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDGAN1996-12-18
62471558018805K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDGAN1996-12-18
62521558018805K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDGAN1996-12-18
2843151558018805K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDGAN1996-12-18
238891176965945K963760NON-SHIELDED SURGICAL TROCAR AND SLEEVEGCJ1997-01-08
148921263419641K963760NON-SHIELDED SURGICAL TROCAR AND SLEEVEGCJ1997-01-08
148931263419641K963760NON-SHIELDED SURGICAL TROCAR AND SLEEVEGCJ1997-01-08
62461353127546K963329ETHICON ENDOSUTURE SYSTEMGCJ1996-10-25
62521353127546K963329ETHICON ENDOSUTURE SYSTEMGCJ1996-10-25
2843151353127546K963329ETHICON ENDOSUTURE SYSTEMGCJ1996-10-25
148921573573703K963329ETHICON ENDOSUTURE SYSTEMGCJ1996-10-25
1052121775375240K963329ETHICON ENDOSUTURE SYSTEMGCJ1996-10-25
238891431464209K962584ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADELFL1996-11-04
148922012537832K962584ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADELFL1996-11-04
148932012537832K962584ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADELFL1996-11-04
1052121415689702K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)GAN1996-03-28
62461592490496K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)GAN1996-03-28
62471592490496K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)GAN1996-03-28
62521592490496K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)GAN1996-03-28
2843151592490496K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)GAN1996-03-28
1052121468576920K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
62461518617461K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
62491518617461K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
62521518617461K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
2843151518617461K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
3315191518617461K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
148921658176054K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
148921056942553K940967MODIFIED ENDOPATH ILSOCW1994-05-27
148931056942553K940967MODIFIED ENDOPATH ILSOCW1994-05-27
148941056942553K940967MODIFIED ENDOPATH ILSOCW1994-05-27
238891490926303K940967MODIFIED ENDOPATH ILSOCW1994-05-27
62461081087910K931492LAPRA-TY* SUTURE CLIPFZP1993-08-24
62471081087910K931492LAPRA-TY* SUTURE CLIPFZP1993-08-24
2843151081087910K931492LAPRA-TY* SUTURE CLIPFZP1993-08-24
62461691224521K931271ETHI-PACK* SURGICAL STAINLESS STEEL SUTUREGAQ1994-01-07
2843151691224521K931271ETHI-PACK* SURGICAL STAINLESS STEEL SUTUREGAQ1994-01-07
148921804547821K931111ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULAGCJ1993-06-22
148931804547821K931111ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULAGCJ1993-06-22
238891810203059K931111ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULAGCJ1993-06-22
62461369145307K925914PRE-TIED LOOP SUTURE CANNULAGCJ1993-05-12
238891948160445K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEGEA1992-04-02
148922055998482K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEGEA1992-04-02
148932055998482K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEGEA1992-04-02
238891297396525K910875ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLEFDP1991-03-19
148921891469713K910875ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLEFDP1991-03-19
148931891469713K910875ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLEFDP1991-03-19
148921246931249K904993LAPAROSCOPIC ELECTROSURGICAL DEVICEGEI1991-01-25
148931246931249K904993LAPAROSCOPIC ELECTROSURGICAL DEVICEGEI1991-01-25
238891768069321K904993LAPAROSCOPIC ELECTROSURGICAL DEVICEGEI1991-01-25
238891800298487K864102LIGACLIP 20/20* MULTIPLE CLIP APPLIERFZP1986-11-05
148932004952348K864102LIGACLIP 20/20* MULTIPLE CLIP APPLIERFZP1986-11-05
1052121035667265K843187CANNULAGEA1984-10-31
62461063365647K843187CANNULAGEA1984-10-31
2843151063365647K843187CANNULAGEA1984-10-31
148921241536960K830503LIGACLIP TITANIUM LIGATING CLIPFZP1983-03-08
148931241536960K830503LIGACLIP TITANIUM LIGATING CLIPFZP1983-03-08
148941241536960K830503LIGACLIP TITANIUM LIGATING CLIPFZP1983-03-08
238891762274534K830503LIGACLIP TITANIUM LIGATING CLIPFZP1983-03-08
148921456331851K820837DISPOSABLE MULTIPLE LIGATING CLIPGDO1982-05-28
148931456331851K820837DISPOSABLE MULTIPLE LIGATING CLIPGDO1982-05-28
238891556745318K820837DISPOSABLE MULTIPLE LIGATING CLIPGDO1982-05-28
62461247486377K812819ETHICON* SURGICAL SUTURES W/COMPRESS BOLKGS1981-11-20
62461115917421K811872TEFLON PLEDGET SUTURE BUTTRESSDXZ1981-08-12
62521115917421K811872TEFLON PLEDGET SUTURE BUTTRESSDXZ1981-08-12
2843151115917421K811872TEFLON PLEDGET SUTURE BUTTRESSDXZ1981-08-12
1052121977178509K811872TEFLON PLEDGET SUTURE BUTTRESSDXZ1981-08-12
62461787432592K810428VICRYLFTL1981-03-13
62471787432592K810428VICRYLFTL1981-03-13
2843151787432592K810428VICRYLFTL1981-03-13
148931083069156K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)GDW2026-05-11
238891244294999K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)GDW2026-05-11
62471358849286K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureGAM2026-02-06
62521358849286K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureGAM2026-02-06
2843151358849286K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureGAM2026-02-06
1052121447601213K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureGAM2026-02-06
1052121654699914K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceGAW2026-03-27
2843152007747037K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceGAW2026-03-27
148931757634342K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC2026-01-09
238892037442439K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC2026-01-09
238891069457388K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)GDW2025-12-17
148931341887954K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)GDW2025-12-17
148931006958798K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)GDW2025-05-14

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GDW1032026-05-11
GAM532026-02-06
GEI452025-01-17
LFL422023-02-28
GCJ352012-10-01
FTL302020-08-06
NEW252025-11-12
FZP202023-08-29
GAQ152017-11-01
GAW122026-03-27
GAN101996-12-18
OMD92021-12-07
HSB72016-09-26
DXZ72000-11-07
LDF62018-08-02
GEA61992-04-02
OXC52026-01-09
OTO52012-06-11
OTN42013-08-23
OCW41994-05-27
GAG32024-07-03
PWJ32018-08-10
MPN32015-10-22
HIF31999-02-03
FDP31991-03-19
MCN31989-09-15
GDO31982-05-28
LMG31960-10-14
FYD22020-06-26
NHB22010-02-17
JDS22004-04-12
QJN12020-07-09
FMF12009-02-20
PAH12005-11-28
HIH11997-09-23
LMF 11985-10-10
KGS11981-11-20

NDC

EVARREST

Ethicon, Inc.

Fibrinogen Human and Human Thrombin

PMA

SURGICEL® Absorbable Hemostats

2022-12-20

ETHICON, INC.1000 Route 202raritan, NJ 08869 PMA NumberN12159 Supplement NumberS096 Date Received11/21/2022 Decision Date12/20/2022 Product Code LMG  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change ...

GYNECARE INTERCEED™ Absorbable Adhesion Barrier

2022-12-20

ETHICON, INC.1000 Route 202raritan, NJ 08869 PMA NumberP880047 Supplement NumberS052 Date Received11/21/2022 Decision Date12/20/2022 Product Code MCN  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - M...

SURGICELTM Family of Absorbable Hemostats

2022-07-08

ETHICON, INC.1000 Route 202raritan, NJ 08869 PMA NumberN12159 Supplement NumberS094 Date Received06/08/2022 Decision Date07/08/2022 Product Code LMG  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change ...

Gynecare Interceed Absorbable Adhesion Barrier

2022-07-08

ETHICON, INC.1000 Route 202raritan, NJ 00869 PMA NumberP880047 Supplement NumberS050 Date Received06/08/2022 Decision Date07/08/2022 Product Code MCN  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - M...

Surgicel Nu-Knit Absorbable Hemostat

2022-05-25

ETHICON, INC.1000 Route 202raritan, NJ 08869 PMA NumberN12159 Supplement NumberS092 Date Received04/26/2022 Decision Date05/25/2022 Product Code LMG  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change ...

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PMN

200 records. Showing 1-40. Next

GUDID

200 records. Showing 1-40. Next