Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

LXC 2026-01-16

MY01 Continuous Compartmental Pressure Monitor

Applicant MY01, Inc.

K-Number K251900

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MYN 2026-01-16

qXR-Detect

Applicant Qure.Ai Technologies

K-Number K251934

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NGX 2026-01-16

CoolTone

Applicant Zimmer Medizinsysteme GmbH

K-Number K253408

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NAY 2026-01-16

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

Applicant Intuitive Surgical, Inc.

K-Number K253556

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LCJ 2026-01-16

Natrelle 133S Tissue Expanders

Applicant AbbVie

K-Number K254126

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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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