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

NDC 2017-03-07

iSage Rx (iSage Rx Basal Insulin Titration)

Applicant Isag Rx, Inc.

K-Number K161865

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HIS 2017-03-07

Male Latex Condoms

Applicant Zhejiang Xiangban Latex Products Co., Ltd.

K-Number K162919

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HSB 2017-03-07

PRECICE Intramedullary Limb Lengthening System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K170346

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HGX 2017-03-07

CIMLRE F1 and CIMILRE S3

Applicant Cimilre Co., Ltd.

K-Number K162870

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DQY 2017-03-07

CenterCross Ultra LV Catheter

Applicant Roxwood Medical, Inc.

K-Number K170403

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MJN 2017-03-07

RenovoCath

Applicant Renovorx, Inc.

K-Number K160067

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JSM 2017-03-06

Greiner Vacuette Urine Count and Culture, Mannitol tube

Applicant Greiner Bio-One Na, Inc.

K-Number K163436

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JWH 2017-03-06

GMK Sphere

Applicant Medacta International S.A.

K-Number K162035

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OLO 2017-03-06

TSolution One Surgical System Model 210

Applicant THINK Surgical, Inc.

K-Number K170430

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KTT 2017-03-06

SALVATION External Fixation System

Applicant Wright Medical

K-Number K162033

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FRO 2017-03-06

Next Science Wound Gel (Rx)

Applicant Next Science, LLC

K-Number K163188

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PHX 2017-03-06

Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw

Applicant Exactech, Inc.

K-Number K162325

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