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

FPA 2022-11-03

NP Medical nCompass Extension Set with Stabilizing Base

Applicant Np Medical

K-Number K221518

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MAX 2022-11-03

ABTross ALIF Expandable Cage System

Applicant Aegis Spine, Inc.

K-Number K221719

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ERL 2022-11-02

ORiGO System

Applicant Bien-Air Surgery SA

K-Number K221184

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FMK 2022-11-02

OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie

Applicant Asahi Polyslider Co., Ltd.

K-Number K222084

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LZA 2022-11-02

Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Brightway Holdings Sdn. Bhd.

K-Number K211816

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LZA 2022-11-02

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Lingshi Hongruida Health Protection Technology Co., Ltd.

K-Number K223320

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LZA 2022-11-02

Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

Applicant Summit Glove, Inc.

K-Number K220371

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HQF 2022-11-02

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

Applicant Ellex Medical Pty, Ltd.

K-Number K222395

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MSX 2022-11-01

Current Health System

Applicant Current Health , Ltd.

K-Number K222550

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IYE 2022-11-01

Klarity SRS Baseplate, Klarity Promise Baseplate

Applicant Klarity Medical & Equipment (GZ) Co., Ltd.

K-Number K220539

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PBX 2022-11-01

Back 3 COLOR

Applicant Swims America Corp

K-Number K214090

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LLZ 2022-11-01

Dolphin Blue Imaging

Applicant Patterson Dental Supply, Inc.

K-Number K221478

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