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

DYB 2019-05-20

VersaCross Transseptal Sheath

Applicant Baylis Medical Company, Inc.

K-Number K183655

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DXN 2019-05-20

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

Applicant Health & Life Co., Ltd.

K-Number K190134

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MMK 2019-05-20

OnSite Waste Sharps Container

Applicant Bluestone Medical, Inc.

K-Number K182235

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PSY 2019-05-20

Aperio AT2 DX System

Applicant Leica Biosystems Imaging, Inc.

K-Number K190332

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MBI 2019-05-19

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

Applicant T.A.G. Medical Products Corporation, Ltd.

K-Number K190125

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OCC 2019-05-18

QIAstat-Dx Respiratory Panel

Applicant QIAGEN GmbH

K-Number K183597

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PHX 2019-05-17

Delta Xtend Reverse Shoulder System

Applicant Depuy(Ireland)

K-Number K183077

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LJE 2019-05-17

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle

Applicant Cook Incorporated

K-Number K183035

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MQF 2019-05-17

Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)

Applicant Cook Incorporated

K-Number K191015

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MMI 2019-05-17

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K190675

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IZL 2019-05-17

DRX-Revolution Mobile X-ray System

Applicant Carestream Health, Inc.

K-Number K191025

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DWF 2019-05-17

CardioGard Emboli Protection Cannula

Applicant Cardiogard Medical, Ltd.

K-Number K182302

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