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

ODP 2026-05-16

BluEX Cervical Expandable Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K260840

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KWL 2026-05-15

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

Applicant Depuy Ireland UC

K-Number K260536

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IYN 2026-05-15

uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super

Applicant Wuhan United Imaging Healthcare Co.,Ltd

K-Number K253716

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DHB 2026-05-15

NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)

Applicant Hycor Biomedical

K-Number K260059

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QEP 2026-05-15

cobas liat CT/NG nucleic acid test

Applicant Roche Molecular Systems, Inc.

K-Number K253756

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QIH 2026-05-15

Neurophet SCALE PET

Applicant Neurophet., Inc.

K-Number K252563

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MAX 2026-05-15

Ventana® P/T Lumbar Interbody System

Applicant Spinal Elements, Inc.

K-Number K260506

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QIH 2026-05-15

Neurophet AQUA

Applicant Neurophet., Inc.

K-Number K261273

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CAH 2026-05-15

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Applicant Teleflex Medical Sdn. Bhd.

K-Number K252643

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IYN 2026-05-15

Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)

Applicant Sonoscape Medical Corp.

K-Number K254028

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BTA 2026-05-15

Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K260134

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QIH 2026-05-15

SubtleHD-CT (1.x)

Applicant Subtle Medical, Inc.

K-Number K254120

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