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

MWI 2026-01-16

WAVE Clinical Platform (2.0.000)

Applicant Baxter Healthcare Corp/ Excel Medical

K-Number K250135

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QIH 2026-01-16

Imagine® Enterprise Suite

Applicant Softlink International Private Limited

K-Number K252634

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DXO 2026-01-16

OptoMonitor 3

Applicant Opsens, Inc.

K-Number K251367

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DTM 2026-01-16

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter

Applicant Medtronic

K-Number K251744

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HKI 2026-01-16

Eyer 2

Applicant Phelcom Technologies

K-Number K251353

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DJG 2026-01-16

LZI Buprenorphine II Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K253082

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GKZ 2026-01-16

Tru Hematology Test

Applicant Truvian Sciences, Inc.

K-Number K251249

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BTT 2026-01-16

FL-10000U Respiratory Humidifier

Applicant Flexicare Medical Limited.

K-Number K251448

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OWB 2026-01-16

Azurion R3.1

Applicant Philips Medical Systems B.V.

K-Number K254186

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ODP 2026-01-16

Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System

Applicant Curiteva, Inc.

K-Number K252205

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PCH 2026-01-16

Xpert GI Panel

Applicant Cepheid

K-Number K251721

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DHB 2026-01-16

NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

Applicant Hycor Biomedical

K-Number K252775

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