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

GXH 2018-11-09

AtriCure cryoICE cryoSPHERE cryoablation probe

Applicant AtriCure, Inc.

K-Number K182565

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KWQ 2018-11-09

Aspida® Anterior Lumbar Plating System

Applicant Alphatec Spine, Inc.

K-Number K182808

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IYN 2018-11-09

EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K182857

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DYW 2018-11-09

Blue Sky Bio Computerized Orthodontic Bracket System

Applicant Blue Sky Bio

K-Number K182338

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PNR 2018-11-09

Enteral Feeding Syringes with Enfit Connectors

Applicant Jiangsu Kangbao Medical Equipment Co., Ltd.

K-Number K182649

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HBB 2018-11-09

ELAN 4 Air Motor System

Applicant Aesculap, Inc.

K-Number K172907

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OLO 2018-11-09

Brainlab Compatible K2M Navigation Instruments

Applicant K2m

K-Number K181890

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MQK 2018-11-09

Cryotop®US-flash and Cryotop®US-scoop

Applicant Kitazato Corporation

K-Number K181469

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IPF 2018-11-09

PowerDot PD-01MT

Applicant Smartmissimo Technologies Pte, Ltd.

K-Number K181759

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DQY 2018-11-09

Teleport Microcatheter

Applicant Orbusneich Medical Trading, Inc.

K-Number K182360

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QDP 2018-11-09

FilmArray Pneumonia Panel

Applicant Biofire Diagnostics, LLC

K-Number K180966

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ODP 2018-11-08

Neurostructures Cavetto® [MAX] Cervical Cage System

Applicant Neurostructures, Inc.

K-Number K181590

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