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

JAK 2019-07-29

Access CT

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K191136

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HRS 2019-07-29

CoLink® Mini Plating System

Applicant In2bones USA, LLC

K-Number K191535

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LSR 2019-07-29

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System

Applicant Zeus Scientific, Inc.

K-Number K191398

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MUE 2019-07-29

Sample Imaging for Senographe Pristina

Applicant GE Healthcare

K-Number K190809

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EIH 2019-07-29

Shaders ZR

Applicant Digital Age Dental Lab

K-Number K190569

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FMF 2019-07-28

Bonus Therapeutics Mixing and Delivery System

Applicant Bonus Therapeutics , Ltd.

K-Number K190996

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HWC 2019-07-26

ActivOrtho Continuous Compression Screw System

Applicant Activortho, Inc.

K-Number K191817

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FYD 2019-07-26

Megadyne Foot Switch

Applicant Megadyne Medical Products, Inc.

K-Number K191328

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CJY 2019-07-26

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

Applicant HORIBA ABX SAS

K-Number K191396

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NAY 2019-07-26

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30

Applicant Intuitive Surgical

K-Number K191736

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LZA 2019-07-26

PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs

Applicant Smart Glove Corporation Sdn. Bhd.

K-Number K183280

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LPH 2019-07-26

Medtronic Total Hip Arthroplasty System

Applicant Medtronic Advanced Energy

K-Number K183129

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