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

MWP 2019-12-27

Volumetric Specimen Imager

Applicant Clarix Imaging

K-Number K192939

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OXN 2019-12-27

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

Applicant Cook Biotech Incorporated

K-Number K191696

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GEI 2019-12-27

InMode System with the Morpheus8 (Fractora) Applicators

Applicant Inmode MD , Ltd.

K-Number K192695

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JDW 2019-12-26

Temporary Fixation Pins

Applicant Eisertech, LLC

K-Number K192768

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GDW 2019-12-26

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool

Applicant Datascope Corp.

K-Number K190884

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OAP 2019-12-26

iHelmet Hair Growth System

Applicant Slinph Technologies Co., Ltd.

K-Number K190467

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LZO 2019-12-26

Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem

Applicant Zimmer GmbH

K-Number K193050

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DQY 2019-12-24

VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)

Applicant MicroVention, Inc.

K-Number K192135

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KCT 2019-12-23

Neodent Instrument Kit Cases

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K190665

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LZA 2019-12-23

Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color

Applicant Ever Growth (Vietnam) Co. , Ltd.

K-Number K190860

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DQY 2019-12-23

RIST Cath Radial Access Long Sheath

Applicant Rist Neurovascular, Inc.

K-Number K191551

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HQB 2019-12-23

MAXReach Laser Probe

Applicant Vortex Surgical, Inc.

K-Number K191846

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