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

EBC 2019-07-29

Helioseal F Plus

Applicant Ivoclar Vivadent, AG

K-Number K190339

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LSR 2019-07-29

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

Applicant Zeus Scientific, Inc.

K-Number K191240

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LSR 2019-07-29

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

Applicant Zeus Scientific, Inc.

K-Number K190907

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PJD 2019-07-29

Quantisal II Oral Fluid Collection Device

Applicant Immunalysis Corporation

K-Number K183048

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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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