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

MAX 2017-03-08

Rampart(TM) T Lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K163409

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FOZ 2017-03-08

Nipro SafeTouch IV Catheter

Applicant Nipro Medical Corporation

K-Number K161681

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GEI 2017-03-08

VIVA combo RF System

Applicant Starmed Co., Ltd.

K-Number K163450

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LHI 2017-03-08

Vial2Bag Direct Connect

Applicant Medimop Medical Project , Ltd.

K-Number K170095

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DZE 2017-03-08

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment

Applicant Straumann USA, LLC

K-Number K162890

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DTN 2017-03-08

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C

Applicant Sorin Group Italia S.R.L.

K-Number K161733

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DXT 2017-03-08

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

Applicant Osprey Medical, Inc.

K-Number K163054

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FPA 2017-03-08

Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set

Applicant Beijing Fert Technology Co., Ltd.

K-Number K161898

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NRY 2017-03-08

Solitaire Platinum Revascularization Device, 6x40 mm

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K160641

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KNT 2017-03-07

Flexi-Seal PROTECT Fecal Management System

Applicant Convatec

K-Number K162906

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KJJ 2017-03-07

Straumann PrefGel

Applicant Institut Straumann AG

K-Number K162311

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DYB 2017-03-07

Vado Steerable Sheath

Applicant Kalila Medical, Inc.

K-Number K160721

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