Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

FEB 2019-07-09

ENDOSCOPE REPROCESSOR OER-Elite

Applicant Olympus Medical Systems Corp.

K-Number K190969

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KMK 2019-07-09

SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F

Applicant Interrad Medical, Inc.

K-Number K180994

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KFM 2019-07-09

LifeSPARC Pump, LifeSPARC Controller

Applicant Cardiacassist, Inc.

K-Number K183623

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MVR 2019-07-09

Gem FlowCoupler System

Applicant Baxter/ Synovis Micro Companies Alliance, Inc.

K-Number K191252

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GEX 2019-07-09

EpiLaze Multi-wavelength Laser

Applicant Rohrer Aesthetics, LLC

K-Number K191162

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IPF 2019-07-09

Shear Stress Therapeutics SST 3000

Applicant Shear Stress Therapeutics, LLC

K-Number K182163

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HHW 2019-07-08

ProVate Vaginal Support

Applicant Contipi Medical , Ltd.

K-Number K190277

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JKA 2019-07-08

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

Applicant Kawasumi Laboratories, Inc.

K-Number K190485

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JAQ 2019-07-08

BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device

Applicant Varian Medical Systems, Inc.

K-Number K191580

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MUJ 2019-07-08

RayCare 2.3

Applicant RaySearch Laboratories AB (PUBL)

K-Number K191384

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OWB 2019-07-08

nView system 1

Applicant Nview Medical, Inc.

K-Number K190064

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FLE 2019-07-08

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves

Applicant Tuttnauer , Ltd.

K-Number K181456

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