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

HSN 2023-10-12

Exactech® Vantage® Total Ankle System

Applicant Exactech, Inc.

K-Number K230717

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DXF 2023-10-12

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable

Applicant Cross Vascular, Inc.

K-Number K232852

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MQC 2023-10-12

FREEPRINT® splintmaster

Applicant Detax GmbH

K-Number K232448

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OLO 2023-10-12

TMINI™ Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K232802

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GEI 2023-10-12

Cross Vascular RF Generator and Footswitch (optional accessory)

Applicant Cross Vascular, Inc.

K-Number K232809

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KGN 2023-10-12

Collagen Wound Dressing

Applicant Winner Medical Co., Ltd.

K-Number K231152

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KTT 2023-10-12

Monkey RingsTM External Fixation System

Applicant Paragon 28, Inc.

K-Number K232838

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DQD 2023-10-12

Stethophone

Applicant Sparrow Acoustics, Inc.

K-Number K231551

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JAK 2023-10-11

NeuViz 128 Multi-Slice CT Scanner System

Applicant Neusoft Medical Systems Co., Ltd.

K-Number K230220

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FRO 2023-10-11

G4Derm / G4Derm Plus Synthetic Wound Matrix

Applicant Gel4med, Inc.

K-Number K222025

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LZA 2023-10-11

Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K232070

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OHT 2023-10-11

IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)

Applicant Shenzhen Lescolton Electrical Appliance Co., Ltd.

K-Number K232499

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