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

ODC 2022-06-01

FROG Forceps Valve (VAL1-F1-100)

Applicant Fujifilm Medwork GmbH

K-Number K221264

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MSX 2022-06-01

BeneVision Central Monitoring System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K220058

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OMP 2022-06-01

Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

Applicant Genadyne Biotechnologies, Inc.

K-Number K210107

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FRA 2022-06-01

Purgo

Applicant Aeroclean Technologies, LLC

K-Number K213753

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OLO 2022-06-01

CoreLink Navigation Instruments

Applicant Corelink, LLC

K-Number K220973

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LHI 2022-06-01

freeflex+ Transfer Adapter

Applicant Fresenius Kabi AG

K-Number K212445

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LZA 2022-06-01

Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.

K-Number K220488

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OHT 2022-06-01

IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K221002

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LLZ 2022-05-31

EchoNavigator R4.0

Applicant Philips Medical Systems Nederland B.V.

K-Number K221270

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LOD 2022-05-31

Bone Cement-Normal Viscosity

Applicant Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda

K-Number K212729

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NXC 2022-05-31

LuxCreo Clear Aligner System

Applicant LuxCreo, Inc.

K-Number K212680

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FQH 2022-05-31

IRRIGO Wound Wash Jet System

Applicant Inopro, Inc.

K-Number K210987

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