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

IZL 2021-04-28

AMX Navigate

Applicant Ge Medical Systems, LLC

K-Number K210982

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FXX 2021-04-28

Medical Mask

Applicant Zhende Medical Co., Ltd.

K-Number K210020

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GEI 2021-04-28

Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps

Applicant Olympus Winter & Ibe GmbH

K-Number K203277

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GEX 2021-04-28

Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber

Applicant Boston Scientific

K-Number K210925

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LPH 2021-04-28

MPACT Extension

Applicant Medacta International S.A.

K-Number K200391

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OWB 2021-04-28

Trinias

Applicant Shimadzu Corporation Medical Systems

K-Number K203535

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PNR 2021-04-28

Oral/Enteral Syringe

Applicant Ningbo Tianyi Medical Appliance Co., Ltd.

K-Number K210621

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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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