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

LLZ 2023-09-01

UniSyn Molecular Imaging (6-3-1)

Applicant Convergent Imaging Solutions

K-Number K231047

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MBI 2023-09-01

Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor

Applicant Arthrex, Inc.

K-Number K232340

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MQB 2023-09-01

MasterX 800 Series

Applicant Medicatech USA

K-Number K230918

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PZL 2023-09-01

OW100S

Applicant Softwave/Trt, LLC

K-Number K231710

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IPF 2023-09-01

DEKA SIMON

Applicant El.En S.P.A.

K-Number K232334

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NHA 2023-09-01

Elos Accurate Hybrid Base

Applicant Elos Medtech Pinol A/S

K-Number K230317

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QSY 2023-09-01

Hemostatic Dressing

Applicant Jiangsu Newvalue Medical Products Co., Ltd.

K-Number K213413

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ODP 2023-09-01

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical

Applicant Ht Medical D.B.A. Xenix Medical

K-Number K222988

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FDS 2023-09-01

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K232314

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OBO 2023-09-01

MS-39

Applicant C.S.O. S.R.L.

K-Number K221601

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NXC 2023-09-01

TRIOCLEAR System

Applicant Modern Dental Laboratory (Dg) Co., Ltd.

K-Number K231884

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FFK 2023-08-31

EL27-Compact; Sterile EHL-Probes

Applicant Walz Elektronik GmbH

K-Number K230488

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