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

QPP 2024-04-24

canturio® se (Canturio Smart Extension)

Applicant Canary Medical USA, LLC

K-Number K234056

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LLZ 2024-04-24

OpenRad Cloud

Applicant Openrad Services Uk, Ltd.

K-Number K240839

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HBL 2024-04-24

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

Applicant Pro Med Instruments GmbH

K-Number K240319

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NGX 2024-04-24

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)

Applicant Hebei JT Medical Co., Ltd.

K-Number K232181

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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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