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

MRH 2020-08-11

OMNI PLUS Surgical System

Applicant Sight Sciences, Inc.

K-Number K201953

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HQF 2020-08-11

LION Photocoagulator

Applicant Norlase Aps

K-Number K201623

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CGS 2020-08-11

Pointe Scientific Creatinine Kinase (CK) Reagent Set

Applicant Medtest DX

K-Number K191296

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EFB 2020-08-11

Disposable High Speed Air Turbine Handpiece

Applicant Ningbo Hpdove Dental Instruments Co., Ltd.

K-Number K193264

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EOB 2020-08-11

HD Video Rhino Laryngoscope

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K200740

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NGT 2020-08-11

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch

Applicant Nurse Assist, LLC

K-Number K201286

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PBX 2020-08-11

NuEra Tight, NuEra Tight EMS

Applicant Bios S.R.L.

K-Number K200359

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NKB 2020-08-11

Mega Plus MIS Spine System

Applicant Bk Meditech, Co., Ltd.

K-Number K200981

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GEH 2020-08-11

CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice

Applicant Varian Medical Systems, Inc.

K-Number K201588

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LNH 2020-08-11

Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Applicant Hyperfine Research, Inc.

K-Number K201722

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HSB 2020-08-10

Precice® Bone Transport System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K201567

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OVD 2020-08-10

Monterey AL Interbody System

Applicant Stryker Corporation

K-Number K201585

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