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

JAK 2020-03-05

CURA 778

Applicant Fmi Medical Systems, Inc.

K-Number K192590

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PJB 2020-03-05

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

Applicant Stereotaxis, Inc.

K-Number K193147

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MSD 2020-03-05

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters

Applicant C. R. Bard

K-Number K190527

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EBF 2020-03-05

Ezfil

Applicant Meta Biomed Co., Ltd.

K-Number K191991

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OWB 2020-03-05

TrackX

Applicant Track X Technology, LLC

K-Number K200360

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OAS 2020-03-05

ProVecta 3D Prime Ceph

Applicant Durr Dental SE

K-Number K193139

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MVL 2020-03-04

Vista Clear

Applicant Inter-Med/Vista Dental Products

K-Number K193389

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GEI 2020-03-04

DANNIK Disposable Monopolar Laparoscopic Instrument

Applicant Dannik

K-Number K193019

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OVE 2020-03-04

Mecta-C Stand Alone

Applicant Medacta International S.A.

K-Number K192906

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QEW 2020-03-04

Capere Thrombectomy System

Applicant Vascular Medcure, Inc.

K-Number K200314

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JAK 2020-03-04

Broncholab

Applicant Fluidda, Inc.

K-Number K191550

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JWJ 2020-03-04

KinematX Total Wrist Arthroplasty System

Applicant Extremity Medical, LLC

K-Number K191525

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