Dental Device Guide
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Manufacturer registered with FDA

Globus Medical Inc

Audubon, PA, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9056090Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
15737 registrations outside the US
Establishments
1United States

Registered in 15 markets

Where regulators' registries name Globus Medical Inc as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedSerbia: 149 registrationsSaudi Arabia: 127 registrationsCosta Rica: 115 registrationsBrazil: 95 registrationsAustralia: 59 registrationsColombia: 49 registrationsUnited Kingdom: 48 registrationsPeru: 33 registrationsHong Kong: 19 registrationsTaiwan: 18 registrationsSouth Korea: 8 registrationsIsrael: 7 registrationsEuropean Union: 6 registrationsCanada: 4 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerGlobus Medical Inc1 device types—Below
SerbiaALIMSManufacturerGlobus Medical, Inc.1492022–2025Pure Global AI
Saudi ArabiaSFDAManufacturerGlobus Medical, Inc.Globus Medical INC.127—Pure Global AI
Costa RicaMinisterio de SaludManufacturerGLOBUS MEDICAL INCGLOBUS MEDICAL, INC. · Globus Medical, Inc.115—Pure Global AI
BrazilANVISAManufacturerGLOBUS MEDICAL, INCGLOBUS MEDICAL INC.952017–2026Pure Global AI
AustraliaTGAManufacturerGlobus Medical Inc592011–2026Pure Global AI
ColombiaINVIMARegistration holderGLOBUS MEDICAL, INC.GLOBUS MEDICAL INC.49—Pure Global AI
United KingdomMHRAManufacturerGlobus Medical, Inc.48—Pure Global AI
PeruDIGEMIDManufacturerGLOBUS MEDICAL, INC.332019–2026Pure Global AI
Hong KongMDDManufacturerGlobus Medical, Inc.192022–2025Pure Global AI
TaiwanTFDAManufacturerGLOBUS MEDICAL, INC.182019–2022Pure Global AI
South KoreaMFDSManufacturerGlobus Medical, Inc.82017–2020Pure Global AI
IsraelAMARManufacturerGlobus Medical IncGlobus Medical Inc. · Globus Medical, Inc.7—Pure Global AI
European UnionEUDAMEDManufacturerGlobus Medical, Inc.6—Pure Global AI
CanadaHealth CanadaRegistration holderGLOBUS MEDICAL, INC.42011–2011Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Globus Medical Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Synthetic Bone Grafting MaterialLYC · Class 2Bone grafts & membranesMaker
Harvest SmartJet
2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Globus Medical Inc lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Harvest Technologies, Corp. (1).

Decided510(k)DeviceApplicantDevice type
3 Jul 2001K011032SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULAHarvest Technologies, Corp.LYC Synthetic Bone Grafting Material

Registered establishments

EstablishmentLocationWhat it does
GLOBUS MEDICAL, INC.FDA reg. 3004142400AUDUBON, PA, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9056090). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.