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Surgical, Inc.

USA · Mansfield

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

12listed device types

Class I 2Class II 10Class III 0

plus 24 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

4active ARTG entries

Class I 4

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 States24 registration records, 15 510(k), 0 PMA, 853 excluded

Brazil0 confirmed, 166 excluded

Saudi Arabia0 confirmed, 54 excluded

Canada0 confirmed, 121 excluded

Manufacturer names merged into this page: G Surgical LLC · G SURGICAL CO., LTD. · E SURGICAL, LLC

FDA 510(k) clearances by year

12000

22006

12007

12008

12011

12015

12016

12017

12019

12021

22023

22024

FDA listed device types

showing 8 of 12

Instrument, Manual, Surgical, General Use 1Tray, Surgical, Instrument 1Electrosurgical, Cutting & Coagulation & Accessories 1Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Arthroscope 1Intervertebral Fusion Device With Bone Graft, Lumbar 1

Market	Identifier	Name	Class / date
US	K240737	G Surgical Marksman MIS System	2024-04-05
US	K233115	Hawkeye Control Unit with Eyas Endoscope	2024-02-06
US	K231126	Eblator Device	2023-08-02

Surgical, 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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