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SurGenTec, LLC

USA · Boca Raton

✓ Record-verifiedregistrations found in 3 markets

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

13listed device types

Class I 3Class II 9Class III 0unclassified 1

plus 34 registration records and 29 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

5active ARTG entries

Class I 1Class III 2IIa 2

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 States34 registration records, 29 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: SURGENTEC LLC

FDA 510(k) clearances by year

12017

12018

12019

32020

12022

42023

92024

42025

52026

FDA listed device types

showing 8 of 13

Filler, Bone Void, Calcium Compound 1Rongeur, Manual 1Instrument, Biopsy 1Arthroscope 1Syringe, Piston 1Neurosurgical Nerve Locator 1Orthopedic Stereotaxic Instrument 1Sacroiliac Joint Fixation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262121	Ion-L Navigated Instruments	2026-07-24
US	K261209	Ion-L	2026-06-11
US	K260329	Ion-C Navigation Instruments	2026-05-22
BR	82007959001	GRAFTGUN TIP	Class II
BR	82007959002	GRAFTGUN	Class II
BR	82007959003	ALARA	Class II

SurGenTec, LLC

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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