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

GEI 2023-11-15

CoolSeal Trinity

Applicant Bolder Surgical, LLC

K-Number K231012

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QYA 2023-11-15

Simple 2 Test

Applicant Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)

K-Number DEN200070

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KTI 2023-11-15

METIC- Airway Balloon Catheter

Applicant M/S Meril Life Sciences Pvt. , Ltd.

K-Number K231818

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EBZ 2023-11-15

Curing Light, Model: MaxCure 9

Applicant Guilin Refine Medical Instrument Co., Ltd.

K-Number K223414

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KRD 2023-11-14

UniPearls® Embolic Microspheres

Applicant Suzhou Haowei Medical Technology Co., Ltd.

K-Number K231554

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EBF 2023-11-14

saremco print BRIDGETEC

Applicant Saremco Dental AG

K-Number K232050

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GKZ 2023-11-14

QScout Lab; QScout RLD

Applicant Ad Astra Diagnostics, Inc.

K-Number K230878

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MBI 2023-11-14

Iconix Anchor

Applicant Riverpoint Medical

K-Number K233468

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OHT 2023-11-14

IPL Cooling Hair Removal Device

Applicant Shenzhen Siken 3D Technology Development Co., Ltd.

K-Number K232845

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LLZ 2023-11-14

BrainSpec Core Software

Applicant Brainspec, Inc.

K-Number K230856

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OZN 2023-11-14

Great Basin Toxigenic C. difficile Direct Test (CDF2)

Applicant Vela Operations USA

K-Number K232092

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NHA 2023-11-14

Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems

Applicant Prismatik Dentalcraft, Inc.

K-Number K231097

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