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Spectra Medical Devices, Inc.

USA · Wilmington

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Israel — 4 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

21listed device types

Class I 9Class II 12Class III 0

plus 22 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

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

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States22 registration records, 8 510(k), 0 PMA, 7 excluded

Brazil6 confirmed, 0 excluded

Manufacturer names merged into this page: SPECTRA MEDICAL DEVICES, LLC · SPECTRA MEDICAL DEVICES, INC.

FDA 510(k) clearances by year

32008 · K082580

12009 · K082689

12011 · K103740

12015 · K142791

12016 · K151069

12017 · K163292

FDA listed device types

showing 8 of 21

Probe, Radiofrequency Lesion 1Set, Anesthesia, Paracervical 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Instrument, Biopsy 1Anesthesia Conduction Kit 1Syringe, Piston 1Introducer, Catheter 1Set, Administration, Intravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163292	Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford	2017-09-08
US	K151069	SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle	2016-02-05
US	K142791	Spectra Soft Tissue Biopsy Needles	2015-01-21
BR	80857100014	cânula para injeção de fármacos guiada por ultrassom e estimulação msk	Class II
BR	80857100012	Cânula Descartável Para Neurotomia	Class II
BR	81189660073	Cânula Bloqueio Sonovisível Oneshot Spectra	Class II

Spectra Medical Devices, 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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