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

HEB 2022-02-25

Cohitech Cottonlock Tampons with Reusable Applicator

Applicant Cotton High Tech S.L.

K-Number K220238

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FLL 2022-02-25

Ear Thermometer, Model ET005, ET008, ET009

Applicant Guangzhou Berrcom Medical Device Co., Ltd.

K-Number K213084

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MOL 2022-02-25

Okamoto 002 Lubricated Polyurethane Male Condom

Applicant Okamoto USA, Inc.

K-Number K203541

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GEI 2022-02-25

Cool-tip RF Ablation System E Series

Applicant Covidien, LLC

K-Number K203150

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IRP 2022-02-25

Normatec 3

Applicant NormaTec Industries, LP

K-Number K220217

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JAK 2022-02-25

OmniTom Elite

Applicant Neurologica Corporation, A Subsidiary of Samsung Electronics

K-Number K211711

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LON 2022-02-25

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

Applicant bioMerieux, Inc.

K-Number K213241

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PHX 2022-02-25

PRIMA Humeral System and SMR Glenosphere Ø42

Applicant Lima Corporate S.P.A.

K-Number K212800

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MNR 2022-02-24

NightOwl

Applicant Ectosense NV

K-Number K220028

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FYA 2022-02-24

Bodygard SFS Surgical Gown Level 3

Applicant Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

K-Number K202845

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QFM 2022-02-24

Annalise Enterprise CXR Triage Pneumothorax

Applicant Annalise-Ai

K-Number K213941

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NXC 2022-02-24

uLab Systems Dental Aligner Kit

Applicant Ulab Systems, Inc.

K-Number K211510

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