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

FPA 2024-12-18

Lyka® PORT Needle Free Access Device (4170Y)

Applicant Quest Medical, Inc.

K-Number K241058

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ILX 2024-12-18

Active System; Avenue8

Applicant Caerus Corporation

K-Number K241395

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EWL 2024-12-18

FirstFit Surgical Kit

Applicant Freudenberg Medical, LLC

K-Number K240763

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JOP 2024-12-18

Falcon/Xpress (Falcon/Xpress)

Applicant Viasonix , Ltd.

K-Number K242662

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FAJ 2024-12-18

Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K242535

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NGL 2024-12-17

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

Applicant Healgen Scientific,, LLC

K-Number K243365

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FGE 2024-12-17

Tornus ES

Applicant Asahi Intecc Co., Ltd.

K-Number K241801

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PSY 2024-12-17

Roche Digital Pathology Dx

Applicant Ventana Medical Systems, Inc.

K-Number K242783

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QLQ 2024-12-17

prodisc® L Instruments

Applicant Centinel Spine, LLC

K-Number K242869

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HHW 2024-12-17

Cntrl+ Bladder Support Pessary

Applicant Cntrl+, Inc.

K-Number K240798

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HKI 2024-12-17

Sentinel Camera

Applicant Ai Optics

K-Number K243664

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EBI 2024-12-17

Lucitone Digital Print Denture System

Applicant Dentsply Sirona, Inc.

K-Number K243336

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