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

GEI 2018-05-23

ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length

Applicant Ethicon Endo-Surgery, LLC

K-Number K180403

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KPS 2018-05-23

Biograph Vision

Applicant Siemens Medical Solutions USA, Inc.

K-Number K180811

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JIL 2018-05-23

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

Applicant DFI Co., Ltd.

K-Number K181024

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DQY 2018-05-23

Route 92 Medical Access System

Applicant Route 92 Medical, Inc.

K-Number K180201

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IPF 2018-05-23

geko T-3 Neuromuscular Stimulator

Applicant Firstkind Limited

K-Number K181059

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ODP 2018-05-23

PATRIOT COLONIAL Spacer, SUSTAIN Spacer

Applicant Globus Medical, Inc.

K-Number K173722

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HRS 2018-05-23

AlignX Ankle Fusion System

Applicant Extremity Medical, LLC

K-Number K181067

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MCW 2018-05-22

Pantheris System

Applicant Avinger, Inc.

K-Number K173862

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GXY 2018-05-22

Reusable and Self-Adhesive Electrodes

Applicant Shaoxing Dongzhi Electrical Technology Co., Ltd.

K-Number K180773

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GWG 2018-05-22

Cellvizio 100 Series Systems with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K180270

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HRS 2018-05-22

Omni Foot Plating System

Applicant Extremity Medical, LLC

K-Number K180808

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MAI 2018-05-22

Arthrex FastThread Interference Screw

Applicant Arthrex, Inc.

K-Number K180662

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