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

JFB 2025-01-31

AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)

Applicant Marzzan Lucas Jorge

K-Number K241193

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FED 2025-01-30

Ureteral Access Sheath

Applicant Seplou (Zhuhai) Co., Ltd.

K-Number K243025

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MBI 2025-01-30

Osprey Suture Anchor

Applicant Responsive Arthroscopy, Inc.

K-Number K243726

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MBI 2025-01-30

WasherCap™ Mini Fixation System (Model 45)

Applicant Abanza Tecnomed S.L

K-Number K243712

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KWS 2025-01-30

MyShoulder Planner (5.3SSWPL)

Applicant Medacta International S.A.

K-Number K241292

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IMK 2025-01-30

iBOT® PMD

Applicant Mobius Mobility

K-Number K243442

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GEX 2025-01-30

BTL-754

Applicant BTL Industries, Inc.

K-Number K241270

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BTT 2025-01-30

Laboratorios Biogalenic Sterile Water for Inhalation, USP

Applicant Laboratorios Biogalenic S.A. DE C.V.

K-Number K242717

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DQA 2025-01-30

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

Applicant Taiwan Aulisa Medical Devices Technologies, Inc.

K-Number K233956

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QYA 2025-01-30

simpli-COLLECT STI Test

Applicant Abbott Molecular

K-Number K243410

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JWY 2025-01-30

MTS Ceftobiprole 0.002-32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K243202

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DXN 2025-01-30

Wrist Blood Pressure Monitor (OHMS11, OHMS12)

Applicant Shenzhen Zhongkemingwang Telecommunications Software Corp.

K-Number K242568

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