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

MAX 2018-05-03

STYLO Interbody Fusion Device

Applicant Legend Spine Technologies

K-Number K180071

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BSO 2018-05-03

Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7

Applicant PAJUNK GmbH Medizintechnologie

K-Number K172777

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DYB 2018-05-03

Micropuncture Pedal Access Set

Applicant Cook Incorporated

K-Number K172980

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INI 2018-05-02

Lite

Applicant Tzora Active Systems , Ltd.

K-Number K172409

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EZN 2018-05-02

Cook 810 Set, Desilets-Hoffman Introducer Set

Applicant Cook Incorporated

K-Number K180028

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CCL 2018-05-02

Accu O2 Oxygen Analyzer

Applicant Precision Medical, Inc.

K-Number K173807

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OLO 2018-05-02

7D Surgical System

Applicant 7D Surgical, Inc.

K-Number K180352

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IYN 2018-05-02

Venue

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K180599

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OLO 2018-05-02

Spineology Navigation Instruments

Applicant Spineology, Inc.

K-Number K180796

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PGX 2018-05-02

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

Applicant Alere Scarborough, Inc.

K-Number K173653

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OLO 2018-05-02

ADAPT for Gamma3

Applicant Stryker GmbH

K-Number K173946

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PZR 2018-05-02

Drug Relief

Applicant Dyansys, Inc.

K-Number K173861

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