Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

KPR 2026-08-27

GC85A

Applicant Samsung Electronics Co., Ltd.

K-Number K260481

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GXY 2026-08-27

Dexus Prosthetic System (MSL2, MSR2)

Applicant Zhejiang Qiangnao Technology Co.,Ltd

K-Number K262654

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NBW 2026-08-27

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K-Number K260545

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FDS 2026-08-27

Disposable Distal Attachment D-201-13404

Applicant Olympus Medical Systems Corporation

K-Number K260856

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KGN 2026-08-27

Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)

Applicant Berkeley Advanced Biomaterials

K-Number K260711

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FMF 2026-08-26

GraftGun Universal Graft Delivery System (GDS®)

Applicant SurGenTec, LLC

K-Number K262581

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FYA 2026-08-26

Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns

Applicant Principle & Will Co., Ltd.

K-Number K260407

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GZF 2026-08-26

StimTrial Neuromodulation System

Applicant Bioventus, LLC

K-Number K253877

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MAH 2026-08-26

Ponto 5 Mini; Ponto 5 Superpower

Applicant Oticon Medical AB

K-Number K261142

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IYE 2026-08-26

MRIA Radiation Therapy Information System (MRIA)

Applicant Manteia Technologies Co., Ltd.

K-Number K260733

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ODP 2026-08-26

VariLift-C Cervical Interbody Fusion System

Applicant Wenzel Spine, Inc.

K-Number K262595

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PIF 2026-08-26

Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)

Applicant Maquet Critical Care AB

K-Number K253715

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