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

ONF 2023-09-11

Venus Versa PRO System

Applicant Venus Concept, Inc.

K-Number K232192

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MWI 2023-09-11

Change Healthcare Cardiology Hemodynamics

Applicant Change Healthcare Israel , Ltd.

K-Number K230881

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HSN 2023-09-11

Vantage® Total Ankle System

Applicant Exactech, Inc.

K-Number K232002

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OVD 2023-09-11

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

Applicant MiRus, LLC

K-Number K232154

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OVY 2023-09-11

VERIFY Spore Test Strip for S40 Sterilant Concentrate

Applicant STERIS Corporation

K-Number K231746

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OHT 2023-09-11

Planar LED mate

Applicant Shenzhen Leaflife Technology Co., Ltd.

K-Number K230362

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HAW 2023-09-09

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

Applicant Brainlab AG

K-Number K223864

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QRK 2023-09-08

STAT Medical Device Lancing System

Applicant Stat Medical Devices

K-Number K230310

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GEX 2023-09-08

KARL STORZ Urological Laser Accessories

Applicant Karl Storz SE & CO. KG

K-Number K230535

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OCX 2023-09-08

Air/Water Bottle Tubing, CO2 Source Tubing

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K231471

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GEI 2023-09-08

AliTight

Applicant Alic Iotech, LLC

K-Number K231146

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SBF 2023-09-08

OnPoint Augmented Reality Spine System

Applicant Onpoint Surgical, Inc.

K-Number K231284

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