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

GDW 2021-04-28

Titan SGS

Applicant Standard Bariatrics

K-Number K210278

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LNH 2021-04-28

TCL3 Motion Tracking System

Applicant Tracinnovations Aps

K-Number K203451

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DQY 2021-04-28

Plato 17 Microcatheter

Applicant Scientia Vascular, LLC

K-Number K210601

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NUC 2021-04-28

Astroglide X Silicone Personal Lubricant

Applicant Biofilm, Inc.

K-Number K210242

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LZO 2021-04-28

BI-MENTUM™ ALTRX® Dual Mobility Liner

Applicant Depuy Ireland UC

K-Number K203532

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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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