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

EOQ 2018-03-28

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor

Applicant Ambu A/S

K-Number K173727

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CHH 2018-03-28

Mission Lipid Panel Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K180504

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LZO 2018-03-28

CoreHip® System

Applicant Aesculap Implants Systems, LLC

K-Number K172235

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LCX 2018-03-28

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette

Applicant Runbio Biotech Co.,Ltd

K-Number K172627

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HIG 2018-03-28

GYN-Pump PH304

Applicant W.O.M. World of Medicine GmbH

K-Number K173489

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HAW 2018-03-28

ROSA BRAIN (v3.0.0.5)

Applicant Medtech S.A

K-Number K172444

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DXO 2018-03-28

PressureWire X

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

K-Number K180558

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LQR 2018-03-28

Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket

Applicant Wilson-Cook Medical, Inc.

K-Number K171969

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EFB 2018-03-28

Concentrix MX-AC High-Speed Handpiece

Applicant Dentalez, Inc.

K-Number K173465

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DRY 2018-03-28

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas

Applicant Spectrum Medical , Ltd.

K-Number K173591

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OVE 2018-03-28

Genesys Spine AIS-C Cervical Anchored Interbody System

Applicant Genesys Spine

K-Number K180056

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GCJ 2018-03-27

AEON Retrieval Bag

Applicant Lexington Medical, Inc.

K-Number K180114

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