Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

OVE 2026-04-27

SABER-C System

Applicant Elevation Spine

K-Number K260660

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EBF 2026-04-27

Grandio disc multicolor

Applicant Voco GmbH

K-Number K261357

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DSY 2026-04-27

Fusion Bioline Vascular Graft

Applicant Maquet Cardiovascular, LLC

K-Number K252445

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ORZ 2026-04-27

TearCare MGX System

Applicant Sight Sciences, Inc.

K-Number K252409

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PDQ 2026-04-26

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

Applicant Tedan Surgical Innovations

K-Number K253580

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NQQ 2026-04-24

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

Applicant ABBOTT MEDICAL

K-Number K253459

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SBF 2026-04-24

Knee+

Applicant Pixee Medical S.A.S.

K-Number K253805

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HRS 2026-04-24

POYA 3.5mm Medial Proximal Tibia System

Applicant Bonebridge AG

K-Number K260228

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DQY 2026-04-24

Amplatzer TorqVue Delivery System

Applicant Abbott

K-Number K260993

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MQV 2026-04-24

Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute

Applicant Stryker Spine

K-Number K261008

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N/A 2026-04-24

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay

Applicant Diazyme Laboratories, Inc.

K-Number K252336

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OQI 2026-04-24

EPORE® XO cup system

Applicant Implantcast GmbH

K-Number K252451

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