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

NKG 2024-03-27

CarboClear® Posterior Cervical Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K233989

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LZA 2024-03-27

Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Ever Growth (Vietnam) Corporation Limited

K-Number K234097

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NEW 2024-03-27

Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)

Applicant Hyundae Meditech Co., Ltd.

K-Number K240389

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QAT 2024-03-27

i-STAT TBI Cartridge with the i-STAT Alinity System

Applicant Abbott Point of Care

K-Number K234143

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NKB 2024-03-27

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K233951

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JAK 2024-03-26

SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed

Applicant Siemens Medical Solutions USA, Inc.

K-Number K233650

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FRO 2024-03-26

PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)

Applicant Medline Industries, LP

K-Number K233151

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PUR 2024-03-26

Removal System Large Bore 60 cc Syringe

Applicant Inari Medical, Inc.

K-Number K233069

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LNH 2024-03-26

SyMRI

Applicant Syntheticmr AB (Publ.)

K-Number K233733

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NHA 2024-03-26

J & P Click Attachments

Applicant J & P Dental Technologies

K-Number K231132

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MQC 2024-03-26

RODIN 3D Resin SPLINT, Hard/Flex

Applicant Belport Company, Inc., Gingi-Pak

K-Number K231793

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DXN 2024-03-26

Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)

Applicant Shenzhen Hingmed Medical Instrument Co., Ltd.

K-Number K231984

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