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

EZD 2026-05-18

Coude Sleeved IC; Coude Plus Sleeved IC

Applicant Hollister Incorporated

K-Number K253295

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EMA 2026-05-18

G-CEM UNIVERSAL

Applicant GC America, Inc.

K-Number K254109

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LLZ 2026-05-18

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

Applicant Cercare Medical A/S

K-Number K253831

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FRG 2026-05-18

HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

Applicant O&M Halyard, Inc.

K-Number K253454

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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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