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

FDI 2018-03-07

Rotatable Snares, Non-Rotatable Snares

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K172758

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GAW 2018-03-07

Aesculap Optilene Nonabsorbable Suture

Applicant Aesculap, Inc.

K-Number K180321

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PEK 2018-03-07

SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System

Applicant Globus Medical, Inc.

K-Number K180156

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EHD 2018-03-07

PORT-X IV

Applicant Genoray Co., Ltd.

K-Number K172810

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GEX 2018-03-07

Dornier Medilas H Solvo 35 Laser

Applicant Dornier Medtech America

K-Number K180350

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NBW 2018-03-07

On Call Express Mobile Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K180196

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GEX 2018-03-07

LMT-3000

Applicant Lameditech Co. , Ltd.

K-Number K172818

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GCJ 2018-03-07

ALVUE Balloon Dilation System

Applicant Globus Medical, Inc.

K-Number K171939

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NUH 2018-03-07

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

Applicant Bayer Healthcare, LLC

K-Number K171802

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PND 2018-03-07

primeMidline Catheters

Applicant Pfm Medical, Inc.

K-Number K173114

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KOD 2018-03-07

Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter

Applicant Cook Incorporated

K-Number K171810

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LNH 2018-03-06

Ingenia Elition S and Ingenia Elition X R5.4

Applicant Philips Medical Systems Nederland B.V.

K-Number K173356

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