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

PID 2019-01-25

Wilson-Cook Achalasia Balloon

Applicant Wilson-Cook Medical, Inc.

K-Number K182895

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HRS 2019-01-25

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K-Number K183321

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EIH 2019-01-25

GenesisZr 4Y Zirconia

Applicant United Dental Resources Corporation

K-Number K182642

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MAX 2019-01-25

NEST Interbody System

Applicant Paonan Biotech Co., Ltd.

K-Number K180230

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PQK 2019-01-25

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle

Applicant Avenu Medical, Inc.

K-Number K183615

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JKA 2019-01-25

MiniCollect K2E K2EDTA Tubes

Applicant Greiner Bio-One Na, Inc.

K-Number K182078

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BSK 2019-01-25

Accucuff Cuff Pressure Indicator

Applicant Tianjin Medis Medical Device Co., Ltd.

K-Number K182548

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GEI 2019-01-24

FLOW 90 Wand

Applicant ArthroCare Corporation

K-Number K183346

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LCM 2019-01-24

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay

Applicant Immunalysis Corporation

K-Number K181135

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LRK 2019-01-24

Zyppah Anti-Snoring Device

Applicant Always More Marketing

K-Number K182312

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NLH 2019-01-24

Reprocessed CS Diagnostic Electrophysiology Catheter

Applicant Stryker Sustainability Solutions

K-Number K181056

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LNH 2019-01-24

MAGNETOM Lumina

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183244

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