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

OLO 2021-01-04

ChoiceSpine Navigation System

Applicant Choice Spine, LLC

K-Number K203561

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PZR 2021-01-02

Sparrow Therapy System

Applicant Spark Biomedical, Inc.

K-Number K201873

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JCT 2020-12-31

HANAROSTENT Trachea/Bronchium (CCC)

Applicant M.I.Tech Co., Ltd.

K-Number K201342

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PZO 2020-12-31

Sim&Size

Applicant Sim&Cure

K-Number K202322

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FXX 2020-12-31

Nordiwell Medical Face Mask

Applicant Changzhou Combat Protective Equipment Co., Ltd.

K-Number K202615

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KXK 2020-12-31

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

Applicant Isoray Medical, Inc.

K-Number K202267

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FMI 2020-12-31

Promisemed Covered Safety Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K202681

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FYA 2020-12-31

Surgical Gown (Sterile), Surgical Gown (Non-sterile)

Applicant B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

K-Number K202706

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NGX 2020-12-31

NuEra Tight Family, EMS Model

Applicant Bios S.R.L.

K-Number K201239

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HPS 2020-12-30

CryoTreQ

Applicant VitreQ BV

K-Number K202038

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ODG 2020-12-30

PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

Applicant Pentax of America, Inc.

K-Number K203166

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KCT 2020-12-30

CrossRoads Tray System

Applicant Crossroads Extremity Systems, LLC

K-Number K202268

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