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 2019-04-18

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

Applicant Beckman Coulter, Inc.

K-Number K190109

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MWI 2019-04-17

SmartLinx Vitals Plus Patient Monitoring System

Applicant Capsule Technologie

K-Number K183638

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DYB 2019-04-17

VersaCross Steerable Sheath, VersaCross Transseptal Dilator

Applicant Baylis Medical Company, Inc.

K-Number K190688

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QEZ 2019-04-17

JETi 88 Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K-Number K183403

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MBI 2019-04-17

Arthrex SwiveLock Anchors

Applicant Arthrex, Inc.

K-Number K190728

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NRY 2019-04-17

0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter

Applicant Imperative Care, Inc.

K-Number K183043

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DXN 2019-04-17

HEM-6410T-ZL Wrist Blood Pressure Monitor

Applicant Omron Healthcare, Inc.

K-Number K190693

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PHL 2019-04-17

Phoenix

Applicant Us Bionics, Inc. (Dba Suitx)

K-Number K183152

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DYB 2019-04-17

M-Y Sheath

Applicant Ram Medical Innovations, Inc.

K-Number K190369

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NFO 2019-04-17

Ultra OTC Facial Toning System

Applicant Micro Current Technology, Inc.

K-Number K183189

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NUC 2019-04-17

JO H2O Jelly Original Personal Lubricant

Applicant United Consortium

K-Number K183584

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KRD 2019-04-17

Dr. Amplatz Micro Plug

Applicant Ka Medical, LLC

K-Number K182944

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