Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

GZT 2018-08-29

Geister retractor for neuro - and spine surgery

Applicant Geister Medizin Technik GmbH

K-Number K180610

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NKB 2018-08-29

CD HORIZON™ Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K182119

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MQL 2018-08-29

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

Applicant Shenzhen Vitavitro Bio-Tech Co., Ltd.

K-Number K180073

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LLZ 2018-08-29

Change Healthcare Enterprise Viewer

Applicant Change Healthcare Canada Company

K-Number K181185

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OVE 2018-08-29

Genesys Spine AIS-C Cervical Stand-Alone System

Applicant Genesys Spine

K-Number K181295

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KWL 2018-08-29

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement

Applicant Osteoremedies, LLC

K-Number K172906

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HIH 2018-08-29

TruClear Elite Hysteroscope

Applicant Covidien

K-Number K180496

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BZR 2018-08-29

Equinox Advantage

Applicant O-Two Medical Technologies, Inc.

K-Number K173205

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LCJ 2018-08-29

Natrelle 133S Tissue Expander

Applicant Allergan

K-Number K182054

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OWI 2018-08-29

ResCUBE™ Ligament Fixation System

Applicant Cousin Biotech Sas

K-Number K181799

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FMI 2018-08-28

Disposable Insulin Pen Needle

Applicant Zhejiang Kindly Medical Devices Co., Ltd.

K-Number K181069

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DPS 2018-08-28

Universal SmartECG

Applicant Vectracor, Inc.

K-Number K173952

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