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

GEI 2020-03-24

PlasmaBlade X 3.0S LIGHT

Applicant Medtronic Navigation

K-Number K193579

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JWH 2020-03-24

Persona Personalized Knee System

Applicant Zimmer, Inc.

K-Number K200209

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GEI 2020-03-24

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch

Applicant Megadyne Medical Products, Inc.

K-Number K193145

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DPW 2020-03-24

FloPatch (FP120)

Applicant Flosonics Medical (R/A 1929803 Ontario Corp.)

K-Number K200337

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NHA 2020-03-24

Sherlock

Applicant Open Implants, LLC

K-Number K193335

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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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