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

DZI 2020-06-30

Surgical Drills

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K200265

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LTT 2020-06-29

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)

Applicant Beckman Coulter, Inc.

K-Number K201423

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NUH 2020-06-29

Electronic stimulator

Applicant Shenzhen Dongjilian Electronics Co., Ltd.

K-Number K200354

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OWB 2020-06-29

ARTIS pheno (VE2)

Applicant Siemens Medical Solution USA, Inc.

K-Number K201156

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HTY 2020-06-29

Arthrex DynaNite K-Wire

Applicant Arthrex, Inc.

K-Number K200068

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DQY 2020-06-29

Twin-Pass Dual Access Catheter

Applicant Vascular Solutions, LLC

K-Number K193119

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HSN 2020-06-29

Cadence Total Ankle System

Applicant Integra LifeSciences Corporation

K-Number K201507

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DQA 2020-06-29

H500 Multi-Sensing Oximetry System

Applicant Nonin Medical, Inc.

K-Number K192900

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GDW 2020-06-29

Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green

Applicant Ethicon Endo-Surgery, LLC

K-Number K200420

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QBY 2020-06-29

Somnera System

Applicant Fresca Medical, Inc.

K-Number K200698

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MQB 2020-06-29

Edge Air(1417) Digital Flat Panel X-ray Detector

Applicant Osko, Inc.

K-Number K201503

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OLO 2020-06-27

OMNIBotics Knee System

Applicant Corin, Ltd.

K-Number K200888

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