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

CAH 2020-03-23

HepaShield Bacterial Viral Breathing System Filter

Applicant Flexicare Medical Limited.

K-Number K191909

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QEP 2020-03-23

Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit

Applicant Hologic, Inc.

K-Number K200436

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PGW 2020-03-23

TruDi Probe

Applicant Acclarent, Inc.

K-Number K193453

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OVE 2020-03-23

NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System

Applicant Nexxt Spine, LLC

K-Number K200543

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HRS 2020-03-23

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range

Applicant Field Orthopaedics Pty, Ltd.

K-Number K200043

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MAX 2020-03-23

CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K191788

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QVO 2020-03-23

Somryst

Applicant Pear Therapeutics, Inc.

K-Number K191716

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PGY 2020-03-23

RadiForce RX1270, RadiForce RX1270-AR

Applicant Eizo Corporation

K-Number K200485

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JDQ 2020-03-23

Sternal Cable System

Applicant A & E Medical Corporation

K-Number K193479

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LPL 2020-03-23

MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC

Applicant CooperVision, Inc.

K-Number K191763

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FXY 2020-03-21

Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover

Applicant Stryker Corporation

K-Number K200493

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OBJ 2020-03-20

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

Applicant Acist Medical Systems, Inc.

K-Number K193183

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