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

MWI 2018-08-08

SmartLinx Vitals Plus Patient Monitoring System

Applicant Capsule Technologie

K-Number K180734

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JWY 2018-08-08

Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL

Applicant Thermo Fisher Scientific

K-Number K181946

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PSZ 2018-08-08

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

Applicant Alere Scarborough, Inc.

K-Number K181853

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DQK 2018-08-08

Pure EP

Applicant Biosig Technologies

K-Number K180805

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DQO 2018-08-08

4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters

Applicant Cordis, A Cardinal Health Company

K-Number K181836

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KGO 2018-08-08

Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs

Applicant Smart Glove Corporation Sdn. Bhd.

K-Number K180221

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HAW 2018-08-08

7D Surgical System Cranial Application

Applicant 7D Surgical, Inc.

K-Number K181041

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FRO 2018-08-07

Surgical Silver Post Operative Dressing

Applicant Advanced Medical Solutions, Ltd.

K-Number K180634

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IYE 2018-08-07

AlignRT Plus

Applicant Vision Rt, Ltd.

K-Number K181218

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GXY 2018-08-07

Self-adhesive Electrode

Applicant Dong Guan OU Kang Electronics Co., Ltd.

K-Number K181234

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LLZ 2018-08-07

CubeVue

Applicant Curvebeam, LLC

K-Number K181962

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MOF 2018-08-07

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile

Applicant Scientia Vascular, LLC

K-Number K181828

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