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

ONB 2018-08-31

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System

Applicant Icu Medical, Inc.

K-Number K173477

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KIF 2018-08-31

BIO-C REPAIR

Applicant Angelus Industria DE Produtos Odontologicos S/A

K-Number K180185

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LRK 2018-08-31

myTAP2

Applicant Airway Management, Inc.

K-Number K181482

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MQV 2018-08-31

ALTAPORE

Applicant Baxter Healthcare Corporation

K-Number K181225

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KWQ 2018-08-31

Cure OPEL-C Plate System

Applicant Meditech Spine, LLC

K-Number K181543

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GCJ 2018-08-30

Dissecting Balloon System

Applicant Applied Medical Resources Corp.

K-Number K182024

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LZO 2018-08-30

b-ONE® Total Hip System

Applicant B-One Ortho, Corp.

K-Number K173380

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GEX 2018-08-30

DEKA Motus AY

Applicant El.En Electronic Engineering Spa

K-Number K181486

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HGM 2018-08-30

Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3

Applicant Edan Instruments, Inc.

K-Number K173042

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MBI 2018-08-30

Arthrex PushLock Tenodesis Anchor

Applicant Arthrex, Inc.

K-Number K181513

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NDN 2018-08-30

SpineJack Expansion Kit

Applicant Vexim SA

K-Number K181262

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LSR 2018-08-30

Sofia 2 Lyme FIA, Sofia Lyme Control Set

Applicant Quidel Corporation

K-Number K173496

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