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ETEX Corporation

USA · Braintree

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Hong Kong, Israel — 6 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

7listed device types

Class I 1Class II 5Class III 0unclassified 1

plus 13 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

1registrations

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 States13 registration records, 25 510(k), 0 PMA

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ETEX Corporation · ETEX CORPORATION

FDA 510(k) clearances by year

11992

11993

11994

11997

11998

22003

42007

12008

52009

42010

12014

12015

12018

12024

FDA listed device types

Filler, Bone Void, Calcium Compound 1Bone Grafting Material, Human Source 1Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) 1Syringe, Piston 1Bone Grafting Material, Synthetic 1Instrument, Manual, Surgical, General Use 1Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions 1

Market	Identifier	Name	Class / date
US	K243609	EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )	2024-12-18
US	K182107	CarriGen PF	2018-08-31
US	K132868	CARRICELL	2015-02-20

ETEX Corporation

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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