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

GEI 2022-08-26

Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer

Applicant Conmed Corporation

K-Number K214058

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FTL 2022-08-26

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Applicant Xiros, Ltd.

K-Number K220091

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QTN 2022-08-26

Vibrant System

Applicant Vibrant, Ltd.

K-Number DEN210052

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MAX 2022-08-25

CONDUIT Lateral Switch Plate

Applicant Medos International SARL

K-Number K221325

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MUJ 2022-08-25

MRI Planner

Applicant Spectronic Medical AB

K-Number K211841

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NBW 2022-08-25

GlucoSure Link Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K212140

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KTT 2022-08-25

ONX Large External Fixation System

Applicant Orthonovis, Inc.

K-Number K213905

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LYZ 2022-08-25

Disposable, vinyl examination gloves, Yellow

Applicant Dezhou Hengchang Medical Technology Co., Ltd.

K-Number K220055

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KTI 2022-08-25

Compass Steerable Needle

Applicant Serpex Medical, Inc.

K-Number K221206

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LYY 2022-08-25

Iconic Latex Glove

Applicant Iconic Medicare Sdn Bhd

K-Number K221648

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MXD 2022-08-25

LINQ II Insertable Cardiac Monitor

Applicant Medtronic, Inc.

K-Number K221962

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NVE 2022-08-25

AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector

Applicant Steris

K-Number K222543

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