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Integra Life Sciences

USA · Planisboro

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan — 5 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

434listed device types

Class I 350Class II 72Class III 5unclassified 7

plus 959 registration records and 97 510(k), 497 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 14Class II 8

31 including historic records

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

6active device licences

Class II 3Class III 3

24 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

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 States959 registration records, 97 510(k), 497 PMA, 24 excluded

Brazil22 confirmed, 12 excluded

Saudi Arabia5 confirmed, 9 excluded

Canada6 confirmed, 11 excluded

Manufacturer names merged into this page: INTEGRA LIFESCIENCES CORPORATION · Integra LifeSciences Corporation · INTEGRA LIFESCIENCE LIMITED

FDA 510(k) clearances by year

52006

72007

22008

42009

52010

42011

62012

32013

82014

32015

62016

32017

72018

52019

32020

22021

22022

12023

12024

22025

FDA listed device types

showing 8 of 434

Syringe, Restorative And Impression Material 1Knife, Nasal 1Cannula, Ventricular 1Strip, Adhesive, Closure, Skin 1Instrument, Contouring, Matrix, Operative 1Drill, Dental, Intraoral 1Gag, Mouth 1Tamp 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251162	CUSA® Clarity Ultrasonic Surgical Aspirator System	2025-10-08
US	K250752	AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)	2025-04-09
US	K240493	CUSA® Clarity Ultrasonic Surgical Aspirator System	2024-07-11
BR	81770370085	Integra® Omni-Tract® Sistema Retrator Monobloco Wishbone®	Class I
BR	81770370066	Sistema de Fixação para Craniotomia Mayfield 2	Class I
BR	81770379004	PINO CRANIAL DESCARTÁVEL DE TITANIO MAYFIELD	Class II
SA	ME0000002136SFDAA00069	Hinged Extension Arm	—
SA	ME0000002136SFDAA00068	FastSystem® Sterile Field Post	—
CA	2803	MINI MULTI-LEAF COLLIMATOR (MMLC)	Class II
CA	11923	DEPTH HELMET, DH-1	Class II
CA	13248	OMNISIGHT IMAGE GUIDED SYSTEM	Class III

Integra Life Sciences

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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