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

GZL 2016-03-04

DNAP Electrode

Applicant Ad-Tech Medical Instrument Corporation

K-Number K152547

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JAA 2016-03-04

Platinum dRF Imaging System

Applicant Apelem-Dms Group

K-Number K160301

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DQY 2016-03-04

MultiCross Catheter

Applicant Roxwood Medical, Inc.

K-Number K152957

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NAY 2016-03-04

IS4000 Stapler 30 Instrument and Stapler 30 Reloads

Applicant Intuitive Surgical, Inc.

K-Number K152421

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GKP 2016-03-03

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)

Applicant Instrumentation Laboratory CO

K-Number K160276

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PEM 2016-03-03

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

Applicant Pac-Dent International, Inc.

K-Number K151123

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EBI 2016-03-03

GC Reline II

Applicant GC America, Inc.

K-Number K153253

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LLZ 2016-03-03

Olea Sphere V3.0

Applicant Olea Medical

K-Number K152602

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FDS 2016-03-03

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

Applicant Fujifilm Medical System U.S.A., Inc.

K-Number K153206

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LFL 2016-03-03

Tenex Health TX System

Applicant Tenex Health, Inc.

K-Number K153299

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PGY 2016-03-03

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

Applicant Qingdao Hisense Medical Equipment Co., Ltd.

K-Number K160347

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MHX 2016-03-03

Passport Series Patient Monitors (Including Passport 8, Passport 12)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K153448

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