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

OCX 2025-05-22

ArgoCap (200.52)

Applicant Ovesco Endoscopy AG

K-Number K242586

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EZN 2025-05-22

Optilume® High Pressure Urological Balloon Dilation Catheter

Applicant Urotronic, Inc.

K-Number K250910

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MEH 2025-05-22

Trivicta® Hip Stem

Applicant Ortho Development Corp.

K-Number K251052

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OHS 2025-05-22

Solawave 2-in-1 Skincare Mini (Model: 61043)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K250532

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HRS 2025-05-22

TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)

Applicant TriMed, Inc.

K-Number K250935

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JWY 2025-05-22

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL

Applicant Thermo Fisher Scientific

K-Number K242659

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NXC 2025-05-21

MEM Clear Aligner System

Applicant Mem Dental Technology Co., Ltd.

K-Number K242637

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QIH 2025-05-21

Synapse 3D Base Tools (V7.0)

Applicant Fujifilm Corporation

K-Number K243762

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LNH 2025-05-21

Swoop® Portable MR Imaging® System

Applicant Hyperfine, Inc.

K-Number K251276

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EBF 2025-05-21

GrandioSO Unlimited

Applicant Voco GmbH

K-Number K251239

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GWG 2025-05-21

HJY VisualNext 3D Endoscopic Vision System

Applicant Hjy Smart Medical Device Co., Ltd.

K-Number K243429

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KGE 2025-05-21

ClearHemograsper

Applicant Finemedix Co., Ltd.

K-Number K242857

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