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

DQX 2019-07-01

ASAHI Silverway

Applicant Asahi Intecc Co., Ltd.

K-Number K183062

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IOR 2019-07-01

IKON 40 Manual Wheelchair

Applicant Broda Seating (Broda Lp)

K-Number K190550

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LON 2019-07-01

BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)

Applicant Becton, Dickinson and Company

K-Number K190905

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BWF 2019-07-01

Hudson RCI Voldyne Volumetric Exerciser

Applicant Teleflexmedical, Inc.

K-Number K182847

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JDR 2019-07-01

TriMed Nitinol Staple System

Applicant TriMed, Inc.

K-Number K190166

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IYO 2019-07-01

LIGHTMED Ultrasound System

Applicant Lightmed USA, Inc.

K-Number K183173

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DRF 2019-07-01

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K190980

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PKL 2019-06-28

ClearEndoclip

Applicant Finemedix Co., Ltd.

K-Number K183021

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ILX 2019-06-28

RecoveryRx

Applicant Bioelectronics Corporation

K-Number K190251

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MBI 2019-06-28

HEALIX ADVANCE Anchor with DYNA+TAPE Sutures

Applicant Medos International SARL

K-Number K191483

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HTN 2019-06-28

MicroLink All-Suture Button Fixation System (Radiopaque)

Applicant Conmed Corporation

K-Number K190582

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NHA 2019-06-28

Straumann CI RD Ceramic Healing Caps

Applicant Institut Straumann AG

K-Number K190654

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