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

NKB 2022-08-09

NextGen Pedicle Screw System

Applicant Corelink, LLC

K-Number K221776

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MMX 2022-08-09

LimFlow V-Ceiver

Applicant LimFlow, Inc.

K-Number K222083

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EBF 2022-08-09

IMICRYL Composite, Composite Flow Materials

Applicant Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K-Number K220077

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GEX 2022-08-09

IRIS Pi Q switched Nd YAG laser

Applicant Bio-Med USA, Inc.

K-Number K221789

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KLE 2022-08-09

DenMat Glutaraldehyde Desensitizer

Applicant Denmat Holding, LLC

K-Number K222357

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QBD 2022-08-08

Dasky Disposable Sampling Tube (Model name: VSM02)

Applicant Ningbo Dasky Life Science Co., Ltd.

K-Number K211675

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LON 2022-08-08

VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)

Applicant bioMerieux, Inc.

K-Number K212243

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MOS 2022-08-08

dS Sentinelle Breast 16ch 1.5T Coil

Applicant Invivo Corporation (Business Trade Name: Philips)

K-Number K213735

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QIH 2022-08-08

ClearPoint Maestro Brain Model

Applicant ClearPoint Neuro, Inc.

K-Number K213645

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MOS 2022-08-08

dS Sentinelle Breast 16ch 3.0T Coil

Applicant Invivo Corporation (Business Trade Name: Philips)

K-Number K213727

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ELW 2022-08-08

Dental Impression Material

Applicant Chemoment Materials Co.,Ltd

K-Number K221668

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LLZ 2022-08-08

Dolphin Imaging 12.0

Applicant Patterson Dental Supply, Inc.

K-Number K222072

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