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

HEB 2019-08-28

FEMME Applicator Tampon

Applicant Jiangsu Yoai Technology Co., Ltd.

K-Number K182142

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KWY 2019-08-28

Implantcast ic-Bipolar Head System

Applicant Implantcast GmbH

K-Number K191569

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HWC 2019-08-28

Interphalangeal Joint Fusion Device Range

Applicant Neosteo

K-Number K191424

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MWI 2019-08-28

B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

Applicant Amzetta Technologies Private Limited

K-Number K182401

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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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