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

DQY 2019-12-15

AXS Vecta Aspiration Catheter

Applicant Stryker Neurovascular

K-Number K190833

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HRS 2019-12-14

Airlock Centrolock Osteosynthesis Implant System

Applicant Novastep

K-Number K192356

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MUJ 2019-12-13

decimal3D

Applicant .Decimal, LLC

K-Number K192554

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GCA 2019-12-13

Tri-Ex Extraction Balloon with Multiple Sizing

Applicant Wilson-Cook Medical, Inc.

K-Number K193344

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NUC 2019-12-13

Satisfaite

Applicant Femmepharma Consumer Healthcare, LLC

K-Number K190752

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GEX 2019-12-13

Diode Laser Therapy System

Applicant San HE Lefis Electronics Co., Ltd.

K-Number K192569

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HRS 2019-12-13

Avanti Distal Radius and Forearm System

Applicant Avanti Orthopaedics, Inc.

K-Number K191118

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KLE 2019-12-13

Ambar, Ambar APS, Ambar Universal APS

Applicant Dentscare Ltda

K-Number K183424

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ERL 2019-12-13

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

Applicant Interscope, Inc.

K-Number K190715

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JAK 2019-12-13

Deep Learning Image Reconstruction

Applicant Ge Healthcare Japan Corporation

K-Number K193170

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FPA 2019-12-13

neria guard Infusion Set

Applicant Unomedical A/S

K-Number K192647

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MQB 2019-12-13

CareView 1800Le

Applicant Careray Digital Medical System Co., Ltd.

K-Number K193173

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