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

MOS 2023-09-01

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K232021

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OLW 2023-09-01

Brain Anesthesia Response Monitor (Bar Monitor)

Applicant Cortical Dynamics , Ltd.

K-Number K213273

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QXJ 2023-09-01

LightStrike+ (MXSUV1-SL and MXSUV1-FT)

Applicant Xenex Disinfection Services, Inc.

K-Number DEN230007

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MQV 2023-09-01

Montage Flowable Settable, Resorbable Bone Paste

Applicant Orthocon, Inc.

K-Number K231270

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EHD 2023-09-01

HyperLight Portable X-ray Unit

Applicant Changzhou Sifary Medical Technology Co., Ltd.

K-Number K232068

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EKX 2023-09-01

InnerView LC

Applicant Perimetrics, Inc.

K-Number K232657

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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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