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

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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MBI 2024-03-26

Grappler Suture Anchor R3FLEX IOL System

Applicant Paragon 28, Inc.

K-Number K240594

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PMN 2024-03-26

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

Applicant Maine Molecular Quality Controls, Inc.

K-Number K233611

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