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Izi Medical Products, Inc.

USA · Owings Mills

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 9 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

16listed device types

Class I 6Class II 10Class III 0

plus 29 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

12 including historic records

TWTaiwanTFDA

8valid device licences

Class I 4Class II 4

SGSingaporeHSA SMDR

4device registrations

CLASS B 2CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

16active ARTG entries

Class I 5IIa 4IIb 1Class Is (sterile) 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

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 States29 registration records, 7 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: IZI MEDICAL PRODUCTS LLC · IZI MEDICAL PRODUCTS, LLC · IZI MEDICAL PRODUCTS, INC. · IZI Medical Products Ltd.

FDA 510(k) clearances by year

12010 · K101373

12014 · K140705

22015 · K143241

12016 · K162265

12019 · K191012

12020 · K200763

FDA listed device types

showing 8 of 16

Instrument, Biopsy 1Arthroscope 1System, Simulation, Radiation Therapy 1Accelerator, Linear, Medical 1System, X-Ray, Tomography, Computed 1Neurological Stereotaxic Instrument 1Bone Cement 1Orthopedic Stereotaxic Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200763	Osteo-site Vertebral Balloon	2020-08-12
US	K191012	Navigated Pedicle Access Kit	2019-08-07
US	K162265	CushionCast Moldable Cushions	2016-11-15
BR	80899110010	osteo-site	Class I
BR	80899119003	BLAZER-C _ Sistema de Vertebroplastia com fio Blazer C	Class II
BR	80899110011	KIT MISTURADOR E INJETOR DE CIMENTO VCF OSTEO-SITE	Class I
SA	ME0000013711SFDAA00011	Multi-Modality Fiducial Markers	—

Izi Medical Products, 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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