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

JOW 2021-02-11

Ezlymph, Ezlymph M

Applicant Eezcare Medical Corp

K-Number K193662

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KIF 2021-02-11

Bio-C Repair Ion+

Applicant Angelus Industria DE Produtos Odontologicos S/A

K-Number K201222

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DXN 2021-02-10

Meditech ABPM-06 (BP6)

Applicant Meditech , Ltd.

K-Number K201332

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GWL 2021-02-10

Digital NeuroPort Biopotential Signal Processing System

Applicant Blackrock Microsystems

K-Number K202174

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FXX 2021-02-10

Standard Procedure Mask, Standard Surgical Mask

Applicant Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

K-Number K202605

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NGX 2021-02-10

SLENDERTONE Evolve Abs, Type 735

Applicant Bio-Medical Research, Ltd.

K-Number K203513

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NAY 2021-02-10

da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments

Applicant Intuitive Surgical, Inc.

K-Number K203632

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LPH 2021-02-10

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing

Applicant Encore Medical L.P.

K-Number K203557

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MUD 2021-02-10

FORE-SIGHT ELITE Absolute Tissue Oximeter

Applicant Edwards Lifesciences, LLC

K-Number K203490

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FLL 2021-02-10

Infrared Forehead Thermometer

Applicant Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.

K-Number K201536

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HGX 2021-02-10

Hi bebe super (Models BT-150S and BT-150L)

Applicant Bistos Co., Ltd.

K-Number K200675

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PDQ 2021-02-10

DSG Connect Technology

Applicant Spineguard S.A.

K-Number K201454

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