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

QBJ 2024-04-23

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K233537

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NRY 2024-04-23

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set

Applicant Route 92 Medical, Inc.

K-Number K233329

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GEI 2024-04-23

mJOULE RF System and Accessories

Applicant Sciton, Inc

K-Number K222958

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HSN 2024-04-23

QUANTUM® Patient Specific Instrumentation (PSI) System

Applicant In2bones Sas

K-Number K231699

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NEY 2024-04-23

swiftPro System

Applicant Emblation Limited

K-Number K240518

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OBJ 2024-04-23

Provisio SLT IVUS System

Applicant Provisio Medical, Inc.

K-Number K233948

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PIB 2024-04-23

AEYE-DS

Applicant Aeye Health, Inc.

K-Number K240058

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GEX 2024-04-23

MeDioStar

Applicant Asclepion Laser Technologies GmbH

K-Number K240816

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GEI 2024-04-23

ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)

Applicant Microline Surgical, Inc.

K-Number K234147

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KLA 2024-04-23

Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)

Applicant Laborie Medical Technologies, Corp.

K-Number K234107

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GEI 2024-04-23

BTL-499

Applicant BTL Industries, Inc.

K-Number K233849

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QBJ 2024-04-23

Dexcom G7 Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K240902

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