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

IYO 2021-05-26

Breast Volume Navigator (BVN) Model G-2000

Applicant Metritrack, Inc.

K-Number K211098

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DQY 2021-05-26

ViperCath XC Peripheral Exchange Catheter

Applicant Cardiovascular Systems, Inc.

K-Number K211251

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DZE 2021-05-26

Implacil Implant System

Applicant Implacil DE Bortoli Material Odontologico Ltda

K-Number K202832

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JOW 2021-05-26

PlasmaWave

Applicant Manamed, Inc.

K-Number K211253

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LPN 2021-05-26

OTE MPS 045 Multi-purpose Lens Care Solution

Applicant Ote North America, LLC

K-Number K210051

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BZH 2021-05-26

Peak flow meter

Applicant Shanghai Sonmol Medical Equipment Co., Ltd.

K-Number K203196

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LQR 2021-05-26

SpyGlass Discover Retrieval Basket

Applicant Boston Scientific Corporation

K-Number K203322

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HSB 2021-05-26

Fassier-Duval Telescopic IM System

Applicant Pega Medical, Inc.

K-Number K211292

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LYZ 2021-05-26

Disposable Synthetic Examination Gloves

Applicant Shandong Shengshixincheng Medical Science & Technology Co.,

K-Number K210520

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FDS 2021-05-25

Pathfinder Endoscope Cap

Applicant Neptune Medical, Inc.

K-Number K210915

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KTT 2021-05-25

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

Applicant Synthes (USA) Products, LLC

K-Number K211313

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QAI 2021-05-25

MicroPen EVO

Applicant Eclipse Medcorp, LLC

K-Number K203144

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