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

HRS 2025-05-30

ARIX Pectus Bar System

Applicant Jeil Medical Corporation

K-Number K242751

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DRE 2025-05-29

VersaCross Connect™ Transseptal Dilator

Applicant Baylis Medical Company, Inc.

K-Number K251325

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ONB 2025-05-29

ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

Applicant Epic Medical Pte. , Ltd.

K-Number K251340

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LXB 2025-05-29

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

Applicant Cochlear

K-Number K250215

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LBI 2025-05-29

BiliWrap

Applicant Gerium Medical, Ltd.

K-Number K243372

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MHX 2025-05-29

Radius VSM and Accessories

Applicant Masimo Corporation

K-Number K250757

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OWX 2025-05-29

SuturePatch Tissue Reinforcement

Applicant Arthrex, Inc.

K-Number K243480

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GEI 2025-05-29

NEUROMARK System (NMK00301)

Applicant Neurent Medical , Ltd.

K-Number K250048

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FMI 2025-05-29

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)

Applicant Terumo Europe N.V.

K-Number K243309

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IYN 2025-05-29

Voluson™ Performance 16; Voluson™ Performance 18

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K250543

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NUH 2025-05-29

TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)

Applicant Shenzhen Astec Technology Co., Ltd.

K-Number K243856

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HRS 2025-05-29

SIGNEX

Applicant Osteonic Co., Ltd.

K-Number K243469

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