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

PMN 2019-06-25

Cepheid Xpert SA Nasal Complete Control Panel

Applicant Microbiologics, Inc.

K-Number K191168

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NLG 2019-06-25

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

Applicant Innovative Health, LLC

K-Number K190785

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GEI 2019-06-25

Radio Frequency Ablation System

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K-Number K190052

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PBX 2019-06-25

Venus Bliss

Applicant Venus Concept USA, Inc.

K-Number K190743

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INI 2019-06-24

Scooter, Model: R-100

Applicant Yongkang Dingchang Industry & Trade Co., Ltd.

K-Number K182411

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MNR 2019-06-24

Maxxi Rip Sensor

Applicant Neurovirtual USA, Inc.

K-Number K171304

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FDA 2019-06-24

FUJIFILM Double Balloon Endoscope EI580BT

Applicant Fujifilm Corporation

K-Number K183032

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DQK 2019-06-24

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle

Applicant Centerline Biomedical, Inc.

K-Number K190106

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OHS 2019-06-24

MMSphere

Applicant Galactic Beauty, LLC

K-Number K190443

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LLZ 2019-06-24

uWS-CT

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K183170

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DXN 2019-06-24

Oscillometric Blood Pressure Monitor

Applicant Rudolf Riester GmbH

K-Number K190927

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MQV 2019-06-23

Orthoss(R)

Applicant Geistlich Pharma AG

K-Number K190754

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