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

DZE 2017-11-21

S.I.N. Dental Implant System

Applicant S.I.N. Sistema DE Implante Nacional S.A.

K-Number K170398

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FRO 2017-11-21

3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing

Applicant 3M Company, 3M Healthcare

K-Number K170754

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GEI 2017-11-21

LAP-iX

Applicant Sejong Medical Co., Ltd.

K-Number K173112

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MQE 2017-11-21

Follicle Aspiration Set, Reduced Single Lumen

Applicant Vitrolife Sweden AB

K-Number K172050

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FRO 2017-11-21

Microcyn Antimicrobial Skin and Wound Cleanser

Applicant Sonoma Pharmaceuticals

K-Number K172622

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DYB 2017-11-21

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath

Applicant Terumo Medical Corporation

K-Number K172995

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DXN 2017-11-21

Automatic Wrist Bluetooth Blood Pressure Monitor

Applicant Truly Instrument , Ltd.

K-Number K170545

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KPS 2017-11-21

Hybrid3D

Applicant Hermes Medical Solutions AB

K-Number K171719

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ELC 2017-11-21

Ultrasonic scaler

Applicant Nanning VV Dental Co., Ltd.

K-Number K163414

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KLE 2017-11-21

Parkell Universal Adhesive

Applicant Parkell, Inc.

K-Number K172176

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KPS 2017-11-21

Hermes Medical Imaging Suite v5.7

Applicant Hermes Medical Solutions AB

K-Number K171681

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LLZ 2017-11-21

MIM Y90 Dosimetry

Applicant Mim Software, Inc.

K-Number K172218

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