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

HBE 2019-06-18

Stryker MIS and Footed Attachments

Applicant Stryker Corporation

K-Number K191049

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KRD 2019-06-18

Torpedo Gelatin Foam

Applicant Biosphere Medical, S.A.

K-Number K183578

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LLZ 2019-06-18

QLAB Advanced Quantification Software 13

Applicant Philips Health Care

K-Number K190913

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BSN 2019-06-17

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

Applicant PAJUNK GmbH Medizintechnologie

K-Number K190663

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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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