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

NHA 2021-04-27

AccelX Abutments

Applicant Integrated Dental Systems, LLC

K-Number K203240

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GEX 2021-04-27

Resonic Rapid Acoustic Pulse Device

Applicant Soliton, Inc.

K-Number K210964

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LPL 2021-04-27

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens

Applicant Vp Optics

K-Number K210609

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NFO 2021-04-27

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device

Applicant Avazzia, Inc.

K-Number K191951

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MBI 2021-04-27

Responsive Arthroscopy Thunderbolt System

Applicant Responsive Arthroscopy, LLC

K-Number K203121

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GCA 2021-04-27

Stone Retrieval Balloon Catheter

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K-Number K210660

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KNT 2021-04-27

Safety Trocar Cannula

Applicant Boston Scientific Corporation

K-Number K211072

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OAN 2021-04-27

STARband, STARlight, St. Louis Band

Applicant Orthomerica Products, Inc.

K-Number K203098

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DRT 2021-04-26

Vital Sign Monitoring Sensor (Model :XK300)

Applicant Xandar Kardian, Inc.

K-Number K202464

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GEX 2021-04-26

Dermatological Diode Laser Systems

Applicant Beijing HuaCheng Taike Technology Co., Ltd.

K-Number K210663

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NXC 2021-04-26

Illusion Aligners

Applicant Laxmi Dental Exports Pvt, Ltd.

K-Number K211010

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FMF 2021-04-26

MicroDose Injector

Applicant Medone Surgical, Inc.

K-Number K203264

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