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

QDC 2018-09-28

Adaptive Biotechnologies clonoSEQ Assay

Applicant Adaptive Biotechnologies Corporation

K-Number DEN170080

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PCH 2018-09-28

BioCode Gastrointestinal Pathogen Panel (GPP)

Applicant Applied BioCode, Inc.

K-Number K180041

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FAD 2018-09-28

Seidmon Antegrade AQ Stent Set

Applicant Cook Incorporated

K-Number K180216

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GAM 2018-09-28

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture

Applicant ETHICON, Inc.

K-Number K181652

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KSB 2018-09-28

Kawasumi Laboratories Blood Drawing Kit (BDK) System

Applicant Kawasumi Laboratories, Inc.

K-Number K172957

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HFG 2018-09-28

Acessa ProVu System

Applicant Acessa Health, Inc.

K-Number K181124

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IYN 2018-09-28

E-CUBE 12

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K181277

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JDI 2018-09-28

Libertas Hip Replacement System

Applicant Maxx Orthopedics, Inc.

K-Number K180973

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MAI 2018-09-28

MICRORAPTOR Knotless Suture Anchor

Applicant Smith and Nephew, Inc.

K-Number K181746

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NFJ 2018-09-28

Harmony

Applicant Topcon Medical Systems, Inc.

K-Number K182376

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DXH 2018-09-28

FibriCheck

Applicant Qompium NV

K-Number K173872

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KCT 2018-09-28

Endoscope Sterilization Tray

Applicant Intuitive Surgical, Inc.

K-Number K180964

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