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

OLO 2019-06-17

GALILEO Spine Alignment Monitoring System

Applicant MiRus, LLC

K-Number K182524

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CDZ 2019-06-17

IDS SHBG

Applicant Immunodiagnostic Systems , Ltd.

K-Number K190121

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EYB 2019-06-17

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter

Applicant Cook Incorporated

K-Number K182695

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QEW 2019-06-17

FlowTriever Retrieval/Aspiration System

Applicant Inari Medical

K-Number K191368

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MAX 2019-06-17

LxHA PEEK Lateral IBF System

Applicant Innovasis, Inc.

K-Number K190684

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DZE 2019-06-17

MRI Compatibility for Existing Straumann Dental Implant Systems

Applicant Straumann USA, LLC

K-Number K190662

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GEX 2019-06-17

Q-Switched Nd: YAG Laser System

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K190936

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NRY 2019-06-16

Penumbra System Reperfusion Catheter JET 7

Applicant Penumbra, Inc.

K-Number K190010

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GEX 2019-06-14

CLARITY II Laser System

Applicant Lutronic Corporation

K-Number K183566

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FLL 2019-06-14

Medline Digital Rectal Thermometer Sheath

Applicant Medline Industries, Inc.

K-Number K183431

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PEM 2019-06-14

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

Applicant Unipack Medical Corporation

K-Number K183263

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HBE 2019-06-14

Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments

Applicant Stryker

K-Number K190172

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