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

LDK 2019-08-28

CryoVizion System

Applicant Cryos Technologies, Inc.

K-Number K183485

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KFM 2019-08-27

Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor

Applicant Medtronic, Inc.

K-Number K191077

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JOW 2019-08-27

Plexus

Applicant Alleva Medical (D.G), Ltd.

K-Number K191107

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NHA 2019-08-26

IPS e.max CAD Abutment Solutions- extra systems

Applicant Ivoclar Vivadent, AG

K-Number K191382

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PCU 2019-08-26

AXIOS Stent and Electrocautery Enhanced Delivery System

Applicant Boston Scientific Corporation

K-Number K192043

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OLO 2019-08-26

Navigated T2 STRATOSPHERE Inserters and Navigated Templates

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K191039

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EBI 2019-08-26

Halley resin system

Applicant Dentsply Sirona

K-Number K191427

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GEX 2019-08-25

810nm Diode Laser System

Applicant Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

K-Number K183122

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JWY 2019-08-23

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

Applicant Liofilchem s.r.l.

K-Number K191809

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MQL 2019-08-23

1-Step Culture Medium

Applicant Shenzhen Vitavitro Biotech Co., Ltd.

K-Number K191063

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FJI 2019-08-23

Hemoflow F3 and F4 Dialyzers

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K190459

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OBR 2019-08-23

CustMBite Dental Guard

Applicant Dental Choice Holdings, LLC

K-Number K183315

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