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

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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GCJ 2023-05-10

HandX Monopolar Scissors

Applicant Human Xtensions , Ltd.

K-Number K230491

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LLZ 2023-05-10

Neurophet AQUA

Applicant Neurophet., Inc.

K-Number K220437

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FRG 2023-05-09

Tyvek Roll with CI for STERLINK Sterilizer

Applicant Plasmapp Co,., Ltd.

K-Number K223025

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NUH 2023-05-09

Tens & Ems Device

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K-Number K223825

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QWI 2023-05-09

Stanza

Applicant Swing Therapeutics, Inc.

K-Number DEN220083

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