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

EIA 2024-02-28

Dental unit Model: Mare

Applicant Foshan Safety Medical Equipment Co., Ltd.

K-Number K231845

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QIH 2024-02-28

CT Cardiomegaly

Applicant Innolitics, LLC

K-Number K232613

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GEI 2024-02-28

OsteoCool 2.0 RF Ablation System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K233830

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SAC 2024-02-28

Technozym ADAMTS13 Activity

Applicant Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM

K-Number DEN230024

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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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