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

NKB 2024-02-27

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM

Applicant Solco Biomedical Copany India Private Limited

K-Number K232607

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KLW 2024-02-27

Peace N Quiet (0.7.0)

Applicant Pnq Health

K-Number K233435

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NGX 2024-02-27

Coresculpt & Magsculpt

Applicant K1Med Co., Ltd.

K-Number K222400

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GEI 2024-02-27

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)

Applicant Maquet Cardiovascular, LLC

K-Number K233879

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EIH 2024-02-27

Obsidian® NOW

Applicant Prismatik Dentalcraft, Inc.

K-Number K234014

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NGT 2024-02-27

Praxiject™ SP 0.9% NaCl

Applicant Medxl, Inc.

K-Number K233623

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ORI 2024-02-27

ARK Levetiracetam II Assay

Applicant Ark Diagnostics, Inc.

K-Number K232522

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OUR 2024-02-27

Camber Sacroiliac (SI) Fixation System

Applicant Camber Spine Technologies

K-Number K233972

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OCT 2024-02-26

GOLFF Sterile Anti-Fog Solution

Applicant Batrik Medical Manufacturing, Inc.

K-Number K231822

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OLW 2024-02-26

BIS™ Advance Monitoring System

Applicant Covidien, LLC

K-Number K230693

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QBJ 2024-02-26

Dexcom G7 Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K234133

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GCA 2024-02-26

Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)

Applicant Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K-Number K232752

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