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

FYA 2021-10-07

Surgical Gown

Applicant Wujiang Tutaike Textiles & Finishing Co., Ltd.

K-Number K211077

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KGN 2021-10-07

NeoMatriX Wound Matrix

Applicant Nextgen Biologics, Inc.

K-Number K210024

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OHT 2021-10-07

Superior Hair Remover

Applicant Guangzhou Haoxingwan Technology Co., Ltd.

K-Number K210376

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MUH 2021-10-07

Digital Intraoral X-ray Imaging System

Applicant Iray Technology Taicang , Ltd.

K-Number K212279

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FDI 2021-10-07

SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)

Applicant STERIS Corporation

K-Number K212860

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MBI 2021-10-06

ActiFlip

Applicant Parcus Medical, LLC

K-Number K212739

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GEX 2021-10-06

Picore

Applicant Bio-Med USA, Inc.

K-Number K212082

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KGO 2021-10-06

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)

Applicant Careplus (M) Sdn Bhd

K-Number K211621

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GXY 2021-10-06

Adhesive Electrodes

Applicant Voncare Medical Device Co., Ltd.

K-Number K212191

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EBF 2021-10-06

TrusFIL Universal Composite Restorative

Applicant Rizhao Huge Biomaterials Company, Ltd.

K-Number K202063

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LZA 2021-10-06

ZinRom Nitrile examination gloves

Applicant Changzhou Xingrong Medical Technology Co., Ltd.

K-Number K211719

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PZP 2021-10-06

AquaBeam Robotic System

Applicant Procept Biorobotics, Corporation

K-Number K212835

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