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

EOQ 2023-01-12

Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set

Applicant Ambu A/S

K-Number K223782

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ODP 2023-01-12

NuVasive Modulus-C Interbody System

Applicant Nuvasive, Inc.

K-Number K223731

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QDA 2023-01-12

Garmin ECG App

Applicant Garmin International, Inc.

K-Number K221774

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GCJ 2023-01-12

HandX Instrument - Monopolar Spatula

Applicant Human Xtensions , Ltd.

K-Number K222011

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KLE 2023-01-12

Rainbow 360

Applicant Kerr Corporation

K-Number K222830

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KWQ 2023-01-11

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System

Applicant Aegis Spine, Inc.

K-Number K223719

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GXY 2023-01-11

Alpha Control Liner System (ACLS)

Applicant Coapt

K-Number K223738

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NKB 2023-01-11

NuVasive Reline System

Applicant Nu Vasive, Incorporated

K-Number K223181

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FDA 2023-01-11

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

Applicant Fujifilm Corporaton

K-Number K223295

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LZA 2023-01-11

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate

Applicant Iconic Medicare Sdn Bhd

K-Number K222181

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QBJ 2023-01-11

Dexcom G6 Continuous Glucose Monitoring (CGM) System

Applicant Dexcom, Inc.

K-Number K223931

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QEW 2023-01-11

Artix BG

Applicant Inari Medical

K-Number K223000

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