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

DQA 2019-10-18

Pulse Oximeter

Applicant Shenzhen Yimi Life-Technology Co., Ltd.

K-Number K191430

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DSH 2019-10-17

Carnation Ambulatory Monitor

Applicant Bardy Diagnostics, Inc.

K-Number K192556

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HGX 2019-10-17

Freestyle Flex

Applicant Medela AG

K-Number K191653

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NBW 2019-10-17

On Call Express II Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K192175

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DXT 2019-10-17

DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System

Applicant Osprey Medical, Inc.

K-Number K190102

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MAI 2019-10-17

Arthrex SwiveLock Anchors

Applicant Arthrex, Inc.

K-Number K192441

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LLZ 2019-10-17

Merge PACS

Applicant Merge Healthcare Incorporated

K-Number K192455

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LLZ 2019-10-17

Voxel Dosimetry™ v1.0

Applicant Hermes Medical Solutions AB

K-Number K191216

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LLZ 2019-10-17

SmartCeph

Applicant Ortho2, LLC

K-Number K190162

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NEU 2019-10-17

EasyMark Tissue Marker

Applicant Inrad, Inc.

K-Number K183503

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GEX 2019-10-17

MT One Diamond

Applicant M&T S.R.L.

K-Number K191942

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GDW 2019-10-17

Reach and CQ'ENCE Circular Staplers

Applicant Reach Surgical, Inc.

K-Number K192566

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