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Data / Medical devices / United States / GD Group USA Company

GD Group USA Company: FDA-registered device maker in Bartlett, IL, United States, 1 510(k) clearance

GD Group USA Company is registered with the FDA (registration 3009542933) in Bartlett, IL, United States. It lists 20 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 17, 2000. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch GD Group USA Company
FDA registration number
3009542933
Address
1286 Humbracht Cir, Bartlett, IL, United States, 60103
Owner or operator
GD Group USA Company (10040438)
Roles
Specification developer
First device listed
April 13, 2012
Registered through
2026
Brand names listed
ACCESSORY, SURGICAL APPAREL, BANDAGE, ELASTIC, BEDDING, DISPOSABLE, MEDICAL, CAP, SURGICAL, COTTON, ROLL, COVER, SHOE, OPERATING-ROOM, Counter, sponge, surgical, DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Specification developeraccessdata.fda.gov
Bandage, ElasticFQM1Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Specification developeraccessdata.fda.gov
Cap, SurgicalFYF1Specification developeraccessdata.fda.gov
Cotton, RollEFN1Specification developeraccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Specification developeraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Specification developeraccessdata.fda.gov
Dissector, TonsilKBM1Specification developeraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Specification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Specification developeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Specification developeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Specification developeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Specification developeraccessdata.fda.gov
Gown, ExaminationFME1Specification developeraccessdata.fda.gov
Non-Surgical GownOEA1Specification developeraccessdata.fda.gov
Pad, EyeHMP1Specification developeraccessdata.fda.gov
Sheet, BurnFPY1Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 17, 2000K001858OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITEKKXSubstantially EquivalentChina Nantong Guangda Textile Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 17, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.