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

JWY 2019-09-04

MTS Imipenem 0.016-256 µg/mL

Applicant Liofilchem s.r.l.

K-Number K191908

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NBY 2019-09-04

GOLNIT Non-aborbable PTFE Surgical Suture

Applicant Antarma, LLC Dba Golnit Sutures

K-Number K192088

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CFN 2019-09-04

Human IgA liquid reagent kit for Use on SPAPlus

Applicant The Binding Site Group , Ltd.

K-Number K192116

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GDW 2019-09-04

Signia Small Diameter Reloads

Applicant Covidien

K-Number K191070

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ELW 2019-09-04

VPS Impression Material

Applicant Hygedent, Inc.

K-Number K191034

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EBF 2019-09-04

Opus Bulk Fill APS, Opus Bulk Fill Flow APS

Applicant Dentscare Ltda

K-Number K190758

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FMF 2019-09-03

5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe

Applicant Top Corporation

K-Number K182765

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DWP 2019-09-03

Geomed Vascular Dilators

Applicant Geomed Medizin-Technik GmbH & Co.

K-Number K183438

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KWQ 2019-09-03

NuVasive® ACP System

Applicant Nu Vasive, Incorporated

K-Number K191500

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HSB 2019-09-03

Syntec Tibial Nail System

Applicant Syntec Scientific Corporation

K-Number K191617

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DYB 2019-09-03

AcQRef Introducer Sheath

Applicant Acutus Medical, Inc.

K-Number K192106

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GEI 2019-08-30

Sutter RaVoR Bipolar Electrodes

Applicant Sutter Medizintechnik GmbH

K-Number K191732

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