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

CAW 2022-06-03

Portable Oxygen Concentrator, model: P2-E6

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K-Number K210371

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MSX 2022-06-03

eCareManager 4.5

Applicant Visicu, Inc.

K-Number K211046

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QAS 2022-06-03

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K221314

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FPA 2022-06-02

Q2 IV Administration Sets

Applicant Quest Medical, Inc.

K-Number K213588

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LZA 2022-06-02

PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves

Applicant O&M Halyard, Inc.

K-Number K220541

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MAX 2022-06-02

Zavation eZspand Interbody System

Applicant Zavation Medical Products, LLC

K-Number K220581

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NCX 2022-06-02

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console

Applicant Zoll Circulation, Inc.

K-Number K220008

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GEX 2022-06-02

Leaseir MHR Xcell

Applicant Leaseir Technologies, Slu

K-Number K214049

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OOX 2022-06-02

Hemosure Accu-Reader A100

Applicant W.H.P.M., Inc.

K-Number K200754

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DQY 2022-06-02

Boss Crossing Support Catheter

Applicant Marvao Medical Devices, Ltd.

K-Number K220632

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LZA 2022-06-02

PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

Applicant O&M Halyard, Inc.

K-Number K220547

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NHA 2022-06-02

Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA

Applicant Institut Straumann AG

K-Number K220751

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