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

NHA 2023-12-05

SS Abutment System

Applicant Osstem Implant Co., Ltd.

K-Number K232220

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MQV 2023-12-05

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty

Applicant Bioventus, LLC

K-Number K233490

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QWR 2023-12-04

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K223783

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MMI 2023-12-04

Access hsTnI

Applicant Beckman Coulter, Inc.

K-Number K230648

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QSY 2023-12-04

RESPONDER Polysaccharide Hemostat

Applicant Starch Medical, Inc.

K-Number K220525

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QZC 2023-12-04

Sonu

Applicant Sound Health Systems, Inc.

K-Number DEN230045

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HRS 2023-12-04

Tyber Medical Distal Radius Plating System

Applicant Tyber Medical, LLC

K-Number K232693

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OHT 2023-12-04

Intense Pulse Light Therapeutic Apparatus

Applicant Shenzhen Greatro Electronic Technology Co., Ltd.

K-Number K232932

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GEH 2023-12-04

Verruca-Freeze® H

Applicant Cryosurgery, Inc.

K-Number K233347

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JKA 2023-12-04

Monarch Blood Collection Set

Applicant The Monarch Company

K-Number K232308

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GXZ 2023-12-04

Medical Disposable Sterile Needle Electrode

Applicant Suzhou Haishen Medical Device Associates Co., Ltd.

K-Number K232581

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JDR 2023-12-04

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples

Applicant Novastep

K-Number K230724

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