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

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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BZD 2019-05-17

WiZARD 310/320 Series CPAP Mask

Applicant Apex Medical Corp.

K-Number K182394

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NHA 2019-05-17

SD Abutment

Applicant Surgident Co., Ltd.

K-Number K173570

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NUC 2019-05-17

KY Banksy Moisture

Applicant Rb Health (Us), LLC

K-Number K183505

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DTZ 2019-05-17

Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac

Applicant Medtronic, Inc.

K-Number K191029

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