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Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)

USA · Cincinnati

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

20listed device types

Class I 7Class II 12Class III 0unclassified 1

plus 236 registration records and 198 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

28registered devices

Class I 3Class II 25

80 including historic records

SASaudi ArabiaSFDA

39registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

15active device licences

Class II 10Class III 5

79 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States236 registration records, 198 510(k), 0 PMA, 10 excluded

Brazil28 confirmed, 8 excluded

Saudi Arabia39 confirmed, 0 excluded

Canada15 confirmed, 6 excluded

Manufacturer names merged into this page: ETHICON ENDO-SURGERY, LLC · ETHICON ENDO-SURGERY, INC. · ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II · ETHICON ENDO-SURGERY INC. · ETHICON ENDO-SURGERY LLC · ETHICON ENDO-SURGERY INC SA DE CV - MEXICO PARA ETHICON ENDO-SURGERY INC

Same-named companies — This database also contains companies with near-identical names: ETHICON ENDO-SURGERY, INC., ETHICON ENDO-SURGERY INC SA DE CV - MEXICO PARA ETHICON ENDO-SURGERY INC, ETHICON ENDO-SURGERY, S.A DE C.V.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

62007

72008

72009

62010

92011

62012

92013

32014

32015

52016

42017

42018

22019

62020

32021

22022

42023

22024

42025

22026

FDA listed device types

showing 8 of 20

Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Tissue Approximation Device 1Electrocautery, Gynecologic (And Accessories) 1Apparatus, Pneumoperitoneum, Automatic 1Laparoscopic Accessories, Esophageal Sizing 1Mesh, Surgical, Absorbable, Staple Line Reinforcement 1Apparatus, Exhaust, Surgical 1Stapler, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260196	ETHICON 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)	2026-05-11
US	K252906	ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)	2026-01-09
US	K252739	ETHICON 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)	2025-12-17
BR	10132590043	TROCARTE CIRURGICO ENDOPATH	Class II
BR	10132590060	TROCARTE CIRURGICO FLEXIVEL FLEXIPATH*	Class II
BR	80145900744	TROCARTES CIRÚRGICOS ENDOPATH XCEL	Class II
SA	ME0000003217SFDAA00033	CIDEX	—
SA	ME0000003217SFDAA00031	APTIMAX	—
CA	4082	PROXIMATE SKIN STAPLER	Class II
CA	10686	MAMMOTOME BIOPSY SYSTEM	Class II
CA	66536	MOMMOTOME EX HAND-HELD SYSTEM	Class II

Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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