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

OHS 2026-08-31

Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)

Applicant Kam Yuen Plastic Products , Ltd.

K-Number K260767

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FPB 2026-08-31

Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter

Applicant Global Life Sciences Solutions USA, LLC

K-Number K261403

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OCC 2026-08-31

ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0

Applicant Abbott Diagnostics Scarborough, Inc.

K-Number K262747

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NFO 2026-08-31

SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)

Applicant Hironic Co., Ltd.

K-Number K260387

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DXN 2026-08-31

Automatic Digital Blood Pressure monitor (LD-526)

Applicant Honsun (Nantong) Co., Ltd.

K-Number K262658

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EBF 2026-08-31

Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)

Applicant Guilin Kevin Peter Technology Co., Ltd.

K-Number K261695

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JOW 2026-08-31

Aerloom

Applicant Evolym, LLC

K-Number K254217

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IYE 2026-08-31

EZFluence (RADEZ V2)

Applicant Radformation, Inc.

K-Number K261718

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HTY 2026-08-28

Primal K-Wire (P99-193-1410)

Applicant Paragon 28, Inc.

K-Number K262722

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PGX 2026-08-28

cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)

Applicant Roche Molecular Systems, Inc.

K-Number K260047

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PDU 2026-08-28

Kiba CTO Crossing Catheter

Applicant Reflow Medical, Inc.

K-Number K262013

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MHX 2026-08-28

Carescape Canvas 1000; Carescape Canvas Smart Display

Applicant GE Healthcare Finland Oy

K-Number K260343

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