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

KGN 2022-07-01

PuraPly Micronized Wound Matrix (PuraPly MZ)

Applicant Organogenesis, Inc.

K-Number K220317

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LPH 2022-07-01

Smith & Nephew Hip Systems

Applicant Smith & Nephew, Inc.

K-Number K211176

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OMP 2022-07-01

Prevena Restor Adapti-Form Dressing

Applicant 3M Healthcare Business Group

K-Number K220660

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FMI 2022-07-01

Insulin Pen Needle

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K221176

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QTF 2022-07-01

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

Applicant Northeast Scientific, Inc.

K-Number K220171

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NKG 2022-07-01

Ennovate Cervical Spinal and Occiput System

Applicant Aesculap Implant Systems, LLC

K-Number K213871

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IYO 2022-07-01

Bladder Scanner, Model Name:M5

Applicant Suzhou Peaksonic Medical Technology Co., Ltd.

K-Number K213488

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EZL 2022-07-01

2-Way 100% Silicone ClearTract Catheter

Applicant Silq Technologies Corporation

K-Number K221625

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MVA 2022-07-01

Hanger Cranial Band 3D

Applicant Symbion Logistics, LLC

K-Number K203134

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MNT 2022-07-01

Nihon Kohden NKV-330 Ventilator System

Applicant Nihon Kohden Orangemed, Inc.

K-Number K213521

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LNH 2022-07-01

i_ Field 1.5T Superconducting Magnetic Resonance Imaging System

Applicant Mri Division,Beijing Wandong Medical Technology Co., Ltd.

K-Number K221025

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EOB 2022-07-01

ENT Nasopharyngoscope and Accessories

Applicant Medimaging Integrated Solution, Inc (Miis)

K-Number K214050

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