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

IYE 2022-05-13

INTDose

Applicant Carina Medical, LLC

K-Number K213137

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NUJ 2022-05-13

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

Applicant Stryker Sustainability Solutions

K-Number K220411

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KDI 2022-05-13

HDF Assist Mudule, HDF Infusion Set and Substitution Filter

Applicant Nephros

K-Number K210575

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MQB 2022-05-13

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG

Applicant Radisen Co., Ltd.

K-Number K221144

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LZA 2022-05-13

Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile

Applicant One Glove Industrial Sdn Bhd

K-Number K220429

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LPL 2022-05-13

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

Applicant Innova Vision, Inc.

K-Number K213119

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FET 2022-05-13

Telepack +

Applicant Karl Storz Endoscopy America, Inc.

K-Number K221174

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KPO 2022-05-12

Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K212620

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FLL 2022-05-12

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

Applicant Alicn Medical Shenzhen, Inc.

K-Number K210937

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LZA 2022-05-12

Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves

Applicant Kl-Kepong Rubber Products Sdn. Bhd.

K-Number K220118

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HQF 2022-05-12

Capsulo

Applicant Quantel Medical

K-Number K220430

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FMF 2022-05-12

Sterile Hypodermic Syringes for Single Use

Applicant Berpu Medical Technology Co., Ltd.

K-Number K213811

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