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

MOB 2018-05-24

EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern

Applicant Euroimmun Us, Inc.

K-Number K172582

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EZN 2018-05-24

Safety Wire Guide Introducer

Applicant Cook Incorporated

K-Number K180756

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LLZ 2018-05-24

McKesson Cardiology

Applicant Change Healthcare Israel , Ltd.

K-Number K181080

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QBX 2018-05-24

T2Bacteria Panel

Applicant T2biosystems, Inc.

K-Number K172708

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DZE 2018-05-24

IS-III HActive Fixture

Applicant Neobiotech Co., Ltd.

K-Number K173938

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IYN 2018-05-24

Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K180862

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MQB 2018-05-24

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

Applicant Pixxgen Corporation

K-Number K180976

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NHA 2018-05-23

Rodo Smilekey

Applicant Rodo Medical, Inc.

K-Number K180609

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GEI 2018-05-23

ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length

Applicant Ethicon Endo-Surgery, LLC

K-Number K180403

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KPS 2018-05-23

Biograph Vision

Applicant Siemens Medical Solutions USA, Inc.

K-Number K180811

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JIL 2018-05-23

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

Applicant DFI Co., Ltd.

K-Number K181024

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DQY 2018-05-23

Route 92 Medical Access System

Applicant Route 92 Medical, Inc.

K-Number K180201

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