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

GEH 2021-01-21

Forwarts

Applicant Pronova Laboratories BV

K-Number K201366

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QEP 2021-01-21

cobas CTNG for use on cobas 6800/8800 systems

Applicant Roche Molecular Systems, Inc.

K-Number K202408

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GDW 2021-01-21

EEA Circular Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K202507

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EIH 2021-01-20

Dentsply Sirona Universal Spray Glazes

Applicant Dentsply Sirona

K-Number K202629

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KLE 2021-01-19

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose

Applicant Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K-Number K192913

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GEI 2021-01-19

Potenza

Applicant Jeisys Medical, Inc.

K-Number K201685

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OBJ 2021-01-19

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203726

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MTJ 2021-01-19

HBP7 Settable Hemostatic Bone Putty

Applicant Orthocon, Inc.

K-Number K202363

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LHD 2021-01-19

Ava Fertility Tracker

Applicant Ava AG

K-Number K200163

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KTT 2021-01-19

Sequel External Fixation Device

Applicant Sequel Medical, Inc.

K-Number K202833

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KXA 2021-01-19

Biocore9 Femoral Head Resurfacing Component

Applicant Biocore9, LLC

K-Number K201219

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MBI 2021-01-19

SnugFit All-Suture Anchor

Applicant Medacta International S.A.

K-Number K203485

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