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

FGE 2018-10-15

Reliant(TM) Multistage Dilatation Balloon Catheter

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K180418

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KLE 2018-10-15

BracePaste MTP Light Cure Primer

Applicant American Orthodontics

K-Number K181910

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QEW 2018-10-15

FlowTriever Retrieval/Aspiration System

Applicant Inari Medical

K-Number K182233

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GEX 2018-10-15

NeuroBlate System

Applicant Monteris Medical,

K-Number K182036

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PHX 2018-10-12

Integra TITAN Reverse Shoulder System

Applicant Integra LifeSciences Corporation

K-Number K181999

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LPL 2018-10-12

ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)

Applicant Vizionfocus, Inc.

K-Number K182247

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MAX 2018-10-12

EIT Cellular Titanium® Lumbar Cage LLIF

Applicant Eit Emerging Implant Technologies GmbH

K-Number K181644

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MOS 2018-10-12

3.0T Air MP M, 3.0T Air MP L

Applicant Ge Healthcare Coils (Usa Instruments, Inc.)

K-Number K182504

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OLO 2018-10-12

ADAPT for Gamma3, Gamma3

Applicant Stryker GmbH

K-Number K181848

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KPS 2018-10-12

uMI 550 PET/CT System

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K182237

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GXR 2018-10-12

OSSDSIGN Cranioplug

Applicant Ossdsign AB

K-Number K181539

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HSB 2018-10-12

X-BOLT Hip Fracture Fixation System

Applicant X-Bolt Orthopaedics

K-Number K181640

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