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

GZI 2019-03-14

L300 Go System

Applicant Bioness, Inc.

K-Number K190285

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GEI 2019-03-14

Aquas Probes

Applicant Genicon, Inc.

K-Number K190168

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NKB 2019-03-14

EUROPA Pedicle Screw System

Applicant MiRus, LLC

K-Number K180337

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NAY 2019-03-14

da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories

Applicant Intuitive Surgical, Inc.

K-Number K182371

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LYR 2019-03-14

Vstrip H. pylori Antigen Rapid Test

Applicant Panion & BF Biotech, Inc.

K-Number K183573

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EBF 2019-03-14

Tetric PowerFill

Applicant Ivoclar Vivadent, AG

K-Number K183380

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DQY 2019-03-13

AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm

Applicant Stryker

K-Number K183463

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GCJ 2019-03-13

Anchor Bag-Alone Tissue Retrieval System by ConMed

Applicant Conmed Corporation

K-Number K183600

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MQB 2019-03-13

Enhanced Feature Software Pack CXDI Series

Applicant Canon, Inc.

K-Number K190368

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DQY 2019-03-13

Venture 0.014 Catheter

Applicant Vascular Solutions, LLC

K-Number K182570

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MQB 2019-03-13

BIOK7600 Flat Panel Detector

Applicant Biokinemetrics, Inc.

K-Number K190311

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NRY 2019-03-13

AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)

Applicant Stryker

K-Number K183464

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