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

DZE 2019-07-03

AlphaDent Implants Dental Implants System

Applicant Alphadent Implants, Ltd.

K-Number K180968

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JAK 2019-07-03

syngo.CT Dual Energy

Applicant Siemens Medical Solutions USA, Inc.

K-Number K191468

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OMP 2019-07-02

PWD Platform Wound Dressing 3” x 5” Oblong

Applicant Applied Tissue Technologies, LLC

K-Number K191460

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NHA 2019-07-02

Certain BellaTek Express and BellaTek Flex Abutments

Applicant Biomet 3i

K-Number K183138

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DQK 2019-07-02

iLab Polaris Multi-Modality Guidance System

Applicant Boston Scientific Corporation

K-Number K191008

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FAJ 2019-07-02

Uro-N Cystoscope

Applicant Uroviu Corporation

K-Number K182876

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LRK 2019-07-02

Twilite Appliance

Applicant Stephen J Harkins, Dds, PC

K-Number K190687

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MCW 2019-07-02

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System

Applicant Cardiovascular Systems, Inc.

K-Number K190634

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PGY 2019-07-02

5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500

Applicant Jvckenwood Corporation

K-Number K191137

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GXY 2019-07-02

Wrap accessory electrodes

Applicant Hi-Dow International, Inc.

K-Number K190617

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DXC 2019-07-02

Site Seal SV

Applicant Ensite Vascular

K-Number K190351

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LNH 2019-07-01

MRopen 0.5 T

Applicant Asg Superconductors S.P.A.

K-Number K190524

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