HomeGLOBUS MEDICAL BRASIL LTDA

GLOBUS MEDICAL BRASIL LTDA

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
103listed device types
Class I 22Class II 77Class III 2unclassified 2
plus 515 registration records and 174 510(k), 9 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
58registered devices
Class I 40Class II 18
135 including historic records
SASaudi ArabiaSFDA
69registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States515 registration records, 174 510(k), 9 PMA, 2 excluded
Brazil58 confirmed, 0 excluded
Saudi Arabia69 confirmed, 0 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: GLOBUS MEDICAL, INC. · GLOBUS MEDICAL BRASIL LTDA · GLOBUS MEDICAL INC. · GLOBUS MEDICAL, INC · Globus Medical INC.

Company information

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

42007
102008
112009
42010
102011
102012
102013
52014
42015
82016
132017
142018
132019
42020
72021
72022
42023
102024
62025
62026

FDA listed device types

showing 8 of 103
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Electrosurgical, Cutting & Coagulation & Accessories 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Cerclage, Fixation 1Neurosurgical Nerve Locator 1Stretcher, Wheeled, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK254043TRIVANCE™ Hip Stem2026-08-04
USK262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)2026-07-31
USK253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System2026-05-07
BR80263050088KIT ESTÉRIL DE CIMENTAÇÃO ÓSSEA SHIELD 3Class II
BR80263050085MISTURADOR ESTÉRIL DE CIMENTAÇÃO ÓSSEA FORTRESS 3Class I
BR80263050089KIT ESTÉRIL DE CIMENTAÇÃO ÓSSEA FORTRESS 2Class I
SAME0000005740SFDAA00087REVERE® 5.5 Clip-On Derotator
SAME0000005740SFDAA00090REVERE® 5.5 Reduction Clip Driver
CA87815PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEMClass III

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