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Advanced Sterilization Products Division of Ethicon, Inc. a Johnson & Johnson Company

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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

6510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

33registered imported devices

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

CACanadaMDALL

5active device licences

Class II 5

11 including historic records

TWTaiwanTFDA

0valid device licences

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 States0 registration records, 6 510(k), 0 PMA, 20 excluded

Brazil0 confirmed, 17 excluded

Saudi Arabia33 confirmed, 1 excluded

Canada5 confirmed, 7 excluded

Manufacturer names merged into this page: ETHICON, INC., ALSO TRADING AS GYNECARE, A DIVISION OF ETHICON, INC. · Advanced Sterilization Products Division of Ethicon,Inc. A Johnson & Johnson Company · Advanced Sterilization Products Division of Ethicon, Inc. a Johnson & Johnson Company · Advanced Sterilization Products, Ethicon Division, A Company of Johnson & Johnson

Same-named companies — This database also contains companies with near-identical names: Advanced Sterilization Products, Ethicon Division, A Company of Johnson & Johnson, ETHICON, INC., ALSO TRADING AS GYNECARE, A DIVISION OF ETHICON, INC., Gynecare, A Div. of Ethicon, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243067	The ETHICON Total Energy System	2025-01-17
US	K990236	MODIFICATION OF JELCO,JELCO-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT	1999-08-20
US	K990395	BARRIER SURGICAL GOWNS	1999-04-13
SA	ME0000003217SFDAA00033	CIDEX	—
SA	ME0000003217SFDAA00031	APTIMAX	—
CA	1226	VERSAPOINT HYSTEROSCOPIC RESECTOSCOPE SYSTEM	Class II
CA	2115	VERSASCOPE HYSTEROSCOPY SYSTEM	Class II
CA	2169	X-TRACT MORCELLATOR	Class II

Advanced Sterilization Products Division of Ethicon, Inc. a Johnson & Johnson Company

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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