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Blackstone Medical, Inc.

USA · Springfield

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 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

45510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 45 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States0 registration records, 45 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: BLACKSTONE MEDICAL INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K093926	FIREBIRD SPINAL FIXATION SYSTEM	2010-07-28
US	K100614	HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES	2010-05-04
US	K092624	FIREBIRD SPINAL FIXATION SYSTEM	2009-09-25
BR	10247530189	Kit Instrumental Centurion - Orthofix	Class I

Blackstone Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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