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

IYO 2023-10-25

K3900 Ultrasound Imaging System

Applicant Maui Imaging

K-Number K230511

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NKB 2023-10-25

PERLA® TL Posterior Thoraco-lumbar Fixation System

Applicant Spineart SA

K-Number K231069

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MBI 2023-10-24

Knotilus+ PEEK Knotless Anchor

Applicant Stryker Endoscopy

K-Number K232683

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NKB 2023-10-24

Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System

Applicant K&J Consulting Corp.

K-Number K232586

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OAP 2023-10-24

Laser Cap, Model: Hat-01

Applicant Hubei Yjt Technology Co.,Ltd

K-Number K232356

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GEI 2023-10-24

PlaDuo System

Applicant ShenB Co., Ltd.

K-Number K232223

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HQF 2023-10-24

VISULAS green

Applicant Carl Zeiss Meditec

K-Number K232051

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GEI 2023-10-24

MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System

Applicant C2dx, Inc.

K-Number K233185

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IMI 2023-10-24

Sonopuls 190

Applicant Enraf-Nonius, B.V.

K-Number K230472

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OWQ 2023-10-24

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

Applicant Vein 360, LLC

K-Number K232584

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IYN 2023-10-24

Aco Apache Ultrasound System

Applicant Aco Healthcare Co., Ltd.

K-Number K231509

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DXN 2023-10-24

Acumen IQ finger cuff

Applicant Edwards Lifesciences, LLC

K-Number K230919

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