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

KIF 2025-02-13

AH Plus Endodontic Sealer

Applicant Dentsply Sirona, Inc.

K-Number K243546

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BSO 2025-02-13

EDEN ControlCath

Applicant Jmt Co., Ltd.

K-Number K241410

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MBH 2025-02-13

Freedom® Total Knee System - Porous Tibial Base Plate

Applicant Maxx Orthopedics, Inc.

K-Number K241597

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ELC 2025-02-13

Integrated Endo System (Meet Endo-II)

Applicant Denjoy Dental Co., Ltd.

K-Number K242317

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OBP 2025-02-13

Ampa One System (AMPA-001)

Applicant Neuromodulatory Devices & Applications

K-Number K243319

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QQX 2025-02-13

Aptima SARS-CoV-2 Assay

Applicant Hologic, Inc.

K-Number K243396

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QZA 2025-02-13

Body Temperature Software (BTS)

Applicant Fitbit, LLC

K-Number K243778

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LNH 2025-02-12

SureWave Elastography (Q7000225)

Applicant Quality Electrodynamics, LLC

K-Number K242006

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MYF 2025-02-12

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls

Applicant Biokit, S.A.

K-Number K243575

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HSB 2025-02-12

Affixus Tibial Nailing System - 4mm screws

Applicant Zimmer, Inc.

K-Number K243907

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KLA 2025-02-12

Fecobionics Anorectal System

Applicant Gi Bionics, LLC

K-Number K242666

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JAK 2025-02-12

NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

Applicant Siemens Medical Solutions USA, Inc.

K-Number K243523

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