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

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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OCX 2022-08-19

OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315

Applicant Cipher Surgical Limited

K-Number K221824

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OLO 2022-08-19

REAL INTELLIGENCE CORI

Applicant Blue Belt Technologies, Inc.

K-Number K221224

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GCJ 2022-08-19

1688 4K Camera System with Advanced Imaging Modality

Applicant Stryker

K-Number K222130

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CCL 2022-08-19

Percent Oxygen Sensors

Applicant Careox, LLC

K-Number K213933

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