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

QVR 2023-09-15

T2 Biothreat Panel

Applicant T2biosystems, Inc.

K-Number K231336

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QNQ 2023-09-15

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

Applicant Poonglim Pharmatech, Inc.

K-Number K221860

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IOR 2023-09-15

Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K232198

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NHA 2023-09-15

LW UCLA Abutment

Applicant Ossvis Co., Ltd.

K-Number K231235

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FED 2023-09-15

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K230752

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IYN 2023-09-15

Carnation series Diagnostic Ultrasound System

Applicant Shenzhen Wisonic Medical Technology Co. , Ltd.

K-Number K230066

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HAW 2023-09-15

ClearPoint Array System (Version 1.2)

Applicant ClearPoint Neuro, Inc.

K-Number K232102

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MSW 2023-09-15

Access Thyroglobulin

Applicant Beckman Coulter, Inc.

K-Number K220972

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NJM 2023-09-14

LightForce Orthodontic System

Applicant Lightforce Orthodontics

K-Number K232827

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QJP 2023-09-14

SOFIA EX Intracranial Support Catheter

Applicant MicroVention, Inc.

K-Number K230775

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MQC 2023-09-14

Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)

Applicant Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.

K-Number K230237

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OAS 2023-09-14

Provecta 3D Prime and Provecta 3D Prime Ceph

Applicant Durr Dental SE

K-Number K232487

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