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

EZD 2016-08-16

PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C

Applicant Adapta Medical, Inc.

K-Number K161445

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GEX 2016-08-16

A.R.C. Laser Surgical Fibers and Probes

Applicant A.R.C Laser GmbH

K-Number K161403

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IMI 2016-08-16

MC1 Plus

Applicant General Project S.R.L.

K-Number K161502

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DZI 2016-08-15

Oral Surgery System and Accessories

Applicant Bonart Co., Ltd.

K-Number K152125

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HRS 2016-08-15

Tarsa-Link Stand-Alone Wedge Fixation System

Applicant Life Spine, Inc.

K-Number K161037

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DXO 2016-08-15

PressureWire X Guidewire

Applicant St. Jude Medical, Inc.

K-Number K161171

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HRS 2016-08-15

Distal Radius Plating System

Applicant Miami Device Solutions, LLC

K-Number K161292

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MQL 2016-08-15

Sydney IVF Gamete Buffer

Applicant William A. Cook Australia Pty. , Ltd.

K-Number K153478

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PGY 2016-08-15

Dell UP3216Q with QUBYX PerfectLum bundle

Applicant Qubyx Software Technologies, Inc.

K-Number K162196

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OUY 2016-08-15

Solana Trichomonas Assay

Applicant Quidel Corporation

K-Number K161182

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DPS 2016-08-12

ECG100+, ECG200+

Applicant Cardioline S.P.A

K-Number K160840

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GEI 2016-08-12

LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp

Applicant Covidien

K-Number K160331

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