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

EBI 2020-11-19

FotoDent denture

Applicant Dreve Dentamid GmbH

K-Number K200580

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PHX 2020-11-19

SMR TT Augmented Glenoid System

Applicant Lima Corporate S.P.A.

K-Number K200171

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FRN 2020-11-19

Sapphire Infusion Pump, Sapphire administration sets

Applicant Q Core Medical , Ltd.

K-Number K192860

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MCW 2020-11-19

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

Applicant Cardiovascular Systems, Inc.

K-Number K203008

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OHS 2020-11-19

Carewear Firefly Wrinkle Reduction

Applicant Carewear Corp.

K-Number K202442

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OUR 2020-11-18

FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K-Number K203138

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GEI 2020-11-18

Viveve System

Applicant Viveve Medical, Inc.

K-Number K200472

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QDQ 2020-11-18

Genius AI Detection

Applicant Hologic, Inc.

K-Number K201019

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GEX 2020-11-18

Chrome

Applicant Quanta System Spa

K-Number K202503

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JWH 2020-11-18

Freedom(R) - TiNbN Coated Knee

Applicant Maxx Orthopedics, Inc.

K-Number K200912

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QEW 2020-11-18

Indigo Aspiration System - Aspiration Catheter 12 and Separator 12

Applicant Penumbra, Inc.

K-Number K202821

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QIH 2020-11-18

syngo.via MI Workflows, syngo MBF

Applicant Siemens Medical Solutions USA, Inc.

K-Number K201195

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