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

OWY 2023-05-11

Regeneten Bioinductive Implant

Applicant Smith and Nephew, Inc.

K-Number K222501

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KTI 2023-05-11

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

Applicant Ga Health Company Limited

K-Number K230280

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JDR 2023-05-11

JAWS Nitinol Staple System

Applicant Paragon 28, Inc.

K-Number K230550

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NPK 2023-05-11

OpenTex

Applicant Purgo Biologics, Inc.

K-Number K222549

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FLL 2023-05-10

Digital Thermometer (Model QT001)

Applicant Shen Zhen Rong Feng Technology Co., Ltd.

K-Number K223044

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LLZ 2023-05-10

Akunah REFLECT

Applicant Akunah Pty, Ltd.

K-Number K222987

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LRK 2023-05-10

Emerald Herbst

Applicant Island Dental Lab, Inc Dba Emerald Dental

K-Number K223624

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NUH 2023-05-10

Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K222870

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LCJ 2023-05-10

Sientra, inc. Portfinder

Applicant Sientra, Inc.

K-Number K221127

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OZI 2023-05-10

Internal Joint Stabilizer - Elbow

Applicant Skeletal Dynamics, Inc.

K-Number K223318

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LBH 2023-05-10

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment

Applicant 3M Espe Dental Products

K-Number K231338

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ITI 2023-05-10

AMP by Method Mobility, AMP Plus (or +) by Method Mobility

Applicant Method Mobility

K-Number K231032

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