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

LIT 2022-08-22

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter

Applicant Cordis US Corp

K-Number K221832

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LJS 2022-08-22

VPS Rhythm DLX Device with TipTracker Technology

Applicant Arrow International, LLC (A subsidiary of Teleflex, Inc.)

K-Number K220363

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HTN 2022-08-22

Arthrex FiberTape and TigerTape Cerclage Sutures

Applicant Arthrex, Inc.

K-Number K221485

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LFL 2022-08-22

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K221835

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DXF 2022-08-22

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

Applicant Edwards Lifesciences, LLC

K-Number K221528

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FMK 2022-08-22

SafetiHeel, MediHeel, Novaplus

Applicant Nsp Tech Pte, Ltd.

K-Number K221604

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LSR 2022-08-19

Viramed Borrela All-In-One ViraChip Test Kit

Applicant Viramed Biotech AG

K-Number K220016

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FRO 2022-08-19

Bonvadis Topical Cream

Applicant Stemcyte, Inc.

K-Number K212554

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QRX 2022-08-19

SmartBolus Calculator

Applicant Insulet Corporation

K-Number K222239

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LLZ 2022-08-19

AXIR-CX

Applicant Radisen Co., Ltd.

K-Number K213520

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HRS 2022-08-19

Baby Gorilla®/Gorilla® Plating System

Applicant Paragon 28, Inc.

K-Number K222194

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QIH 2022-08-19

MI View&GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K222172

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