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

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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NHB 2026-01-16

SeptAlign

Applicant Spirair, Inc.

K-Number K251790

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QJP 2026-01-16

Toro 88 Superbore Catheter

Applicant Toro Neurovascular, Inc.

K-Number K252297

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NAY 2026-01-16

da Vinci Surgical System (IS5000)

Applicant Intuitive Surgical, Inc.

K-Number K251739

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GZJ 2026-01-16

actiTENS mini

Applicant Sublimed

K-Number K252767

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