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

ODP 2020-09-03

Cavetto [MAX] Cervical Cage System

Applicant Neurostructures, Inc.

K-Number K201769

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FMF 2020-09-03

3D GraftRasp System

Applicant Surgentec

K-Number K201900

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MSD 2020-09-03

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

Applicant Medical Components, Inc. (dba MedComp)

K-Number K202176

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BTA 2020-09-03

Cliq Aspirator

Applicant Anest Iwata Sparmax Co., Ltd.

K-Number K201203

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JAA 2020-09-03

ArtPIX DRF

Applicant Cmt Medical Technologies, Ltd.

K-Number K202235

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ITI 2020-09-03

BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair

Applicant 21st Century Scientific, Inc.

K-Number K193599

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OLO 2020-09-02

ExactechGPS System

Applicant Blue Ortho

K-Number K193618

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NQQ 2020-09-02

ApolloVue S100 Image System

Applicant Apollo Medical Optics, Ltd.

K-Number K201552

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NHA 2020-09-02

LOCATOR R-Tx

Applicant Ivory Super Holdco, Incp.

K-Number K200827

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KFM 2020-09-02

Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22

Applicant Qura S.R.L

K-Number K202169

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NRY 2020-09-02

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

Applicant Imperative Care, Inc.

K-Number K202182

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OBJ 2020-09-02

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter

Applicant Philips Image Guided Therapy Corporation

K-Number K200812

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