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

QVP 2025-12-17

Elecsys Anti-SARS-CoV-2

Applicant Roche Diagnostics

K-Number K253839

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NKB 2025-12-17

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Applicant S.M.A.I.O

K-Number K253721

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DQY 2025-12-17

Amplatzer Piccolo Delivery System (9-PDS-04F-045)

Applicant ABBOTT MEDICAL

K-Number K252417

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GDW 2025-12-17

ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T)

Applicant Ethicon Endo-Surgery, LLC

K-Number K252739

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MHX 2025-12-17

Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)

Applicant Shenzhen Comen Medical Instruments Co.,Ltd

K-Number K250854

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QIH 2025-12-17

Neosoma Brain Mets

Applicant Neosoma, Inc.

K-Number K252922

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QLR 2025-12-16

Companion Spine DIAM Instrumentation

Applicant Companion Spine France

K-Number K253118

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FDS 2025-12-16

PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)

Applicant Pentax of America, Inc.

K-Number K251256

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IYE 2025-12-16

IDENTIFY (5.0)

Applicant Varian Medical Systems, Inc.

K-Number K252919

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SCV 2025-12-16

Versius Surgical System (Versius Plus)

Applicant Cmr Surgical Limited

K-Number K252111

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DXQ 2025-12-16

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

Applicant Baxter Healthcare Corporation

K-Number K251745

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HSX 2025-12-16

Cambridge Partial Knee

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K251771

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