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

HWC 2017-08-18

Medline UNITE® Snap-Off Screws

Applicant Medline Industries, Inc.

K-Number K170782

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PYN 2017-08-18

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

Applicant Id-Fish Technology, Inc.

K-Number DEN160025

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DQK 2017-08-18

QUANTIEN Measurement System

Applicant St. Jude Medical (Now Part of the Abbott Medical)

K-Number K172182

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NKG 2017-08-18

Connector System

Applicant Orthofix, Inc.

K-Number K172194

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HWC 2017-08-18

ExsoMed ArcPhix and ExsoMed ArrowPhix

Applicant Exsomed Holding Company, LLC

K-Number K171407

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JAK 2017-08-18

ScannerSide DoseCheck

Applicant Right Dose, Inc.

K-Number K171261

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DRQ 2017-08-18

ACIST RXi Mini System

Applicant Acist Medical Systems, Inc.

K-Number K172216

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KGO 2017-08-18

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K171898

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LAO 2017-08-18

ARK Methotrexate Assay

Applicant Ark Diagnostics, Inc.

K-Number K163359

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KRD 2017-08-18

EMBA Hourglass Peripheral Embolization Device

Applicant Emba Medical Limited

K-Number K171845

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DRG 2017-08-18

Optum TeleHealth Application

Applicant United Health Group, Inc.

K-Number K171406

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LRK 2017-08-18

SnoreRx

Applicant Apnea Sciences Corporation

K-Number K170825

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