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

OAP 2018-06-01

Hair Up

Applicant Y & J Bio Co., Ltd.

K-Number K180617

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OMP 2018-06-01

Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System

Applicant Kci USA, Inc.

K-Number K180855

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BSP 2018-06-01

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters

Applicant Smiths Medical Asd, Inc.

K-Number K172410

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GEI 2018-06-01

InMode System with Fractora3D/3D-90 Applicators

Applicant Inmode MD , Ltd.

K-Number K180189

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DZE 2018-06-01

UF(II) Wide Fixture

Applicant Dio Corporation

K-Number K173975

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KPL 2018-06-01

Colonic Plus Regular, Small, and Straight Shape Hydrokit

Applicant Colonic Plus

K-Number K180800

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NXC 2018-06-01

Smart Moves Complete

Applicant Great Lakes Orthodontics, Ltd.

K-Number K172765

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LZG 2018-06-01

Omnipod DASH Insulin Management System

Applicant Insulet Corporation

K-Number K180045

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DQK 2018-06-01

CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT

Applicant Biosense Webster, Inc.

K-Number K180238

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LLZ 2018-05-31

Interventional Workspot

Applicant Philips Medical Systems Nederland B.V.

K-Number K181177

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JDQ 2018-05-31

Sternal Cable System

Applicant A & E Medical Corporation

K-Number K180582

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IYN 2018-05-31

ACUSON SC2000 Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K181098

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