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

GAW 2022-12-09

Vesseal

Applicant Lydus Medical , Ltd.

K-Number K221280

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MRW 2022-12-09

PMT Facet Fixation System (PMT FFS)

Applicant Providence Medical Technology, Inc.

K-Number K220951

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JOW 2022-12-09

AIROS 8P Sequential Compression Device

Applicant Airos Medical, Inc.

K-Number K223193

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JOW 2022-12-09

AIROS 6P Sequential Compression Device

Applicant Airos Medical, Inc.

K-Number K223195

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JCX 2022-12-09

120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)

Applicant Stryker Instruments

K-Number K222552

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CAW 2022-12-09

Inogen Rove 4 Portable Oxygen Concentrator

Applicant Inogen

K-Number K222086

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GGP 2022-12-09

HemosIL von Willebrand Factor Antigen

Applicant Instrumentation Laboratory CO

K-Number K223402

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JEY 2022-12-09

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate

Applicant Stryker Craniomaxillofacial (Cmf)

K-Number K222650

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FMF 2022-12-09

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe

Applicant Medline Industries, Inc.

K-Number K213054

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HGX 2022-12-09

Wearable breast pump

Applicant Mayborn (Uk) Limited

K-Number K221598

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EBZ 2022-12-08

LED Curing Light

Applicant Foshan Coxo Medical Instrument Co., Ltd.

K-Number K220826

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MAX 2022-12-08

Southern Transforaminal Lumbar Interbody Fusion (TLIF)

Applicant Southern Medical (Pty) , Ltd.

K-Number K221182

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