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DePuy Mitek, Inc.

USA · Raynham

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Hong Kong, Israel, Russia — 8 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

82listed device types

Class I 48Class II 34Class III 0

plus 261 registration records and 81 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

24registered devices

Class I 4Class II 20

40 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

13active device licences

Class II 2Class III 11

22 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

6device registrations

CLASS B 2CLASS C 2CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

3valid listings

Class IV 3

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

13active registrations

Class 1 10Class 2a 1Class 3 2

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 States261 registration records, 81 510(k), 0 PMA, 4 excluded

Brazil24 confirmed, 0 excluded

Canada13 confirmed, 0 excluded

Manufacturer names merged into this page: DePuy Mitek, Inc. · DEPUY MITEK · DEPUY MITEK, INC.

Same-named companies — This database also contains companies with near-identical names: Depuy Mitek, Inc., A Johnson and Johnson Company, Depuy Mitek Inc., Johnson and Johnson Company. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

132004

42005

62006

32007

62008

32009

52010

62011

92012

122013

62014

32015

32024

12025

12026

FDA listed device types

showing 8 of 82

Electrosurgical, Cutting & Coagulation & Accessories 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented 1Light, Surgical, Connector 1Prosthesis, Finger, Constrained, Polymer 1System, Irrigation, Urological 1Screw, Fixation, Bone 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253791	PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid	2026-02-26
US	K243790	GRYPHON X Anchor; HEALIX TRANSTEND Anchor	2025-02-05
US	K241010	HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors	2024-09-11
BR	80145901485	TUBO FMS	Class II
BR	80145909086	FMS VUE II	Class II
BR	80145901439	LÂMINA DE SHAVER FMS	Class II
CA	26	INOVASIVE ROC SUTURE BONE FASTENER	Class III
CA	63	INNOVASIVE LINX HT LIGAMENT FASTENER	Class III
CA	92	INNOVASIVE BIOROC EZ FASTENER	Class III

DePuy Mitek, Inc.

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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