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

IYN 2024-03-22

Digital Ultrasonic Diagnostic Imaging System (Model: F6)

Applicant Guangdong Youkey Medical Co., Ltd.

K-Number K231930

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DRT 2024-03-22

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

Applicant Murata Vios, Inc.

K-Number K232354

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ODC 2024-03-22

Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector

Applicant Medivators (A Subsidiary of Steris Corporation)

K-Number K232067

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FRO 2024-03-22

Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)

Applicant Coloplast Corp.

K-Number K231953

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CEW 2024-03-22

Elecsys PTH , Elecsys PTH STAT

Applicant Roche Diagnostics

K-Number K231927

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BYI 2024-03-22

The Vest APX System (PVAPX1)

Applicant Baxter Healthcare Corportation

K-Number K233441

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KWQ 2024-03-22

STRUXXURE® MCS Anterior Cervical Plate System

Applicant Nexxt Spine

K-Number K240690

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JTN 2024-03-22

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K-Number K231806

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LNH 2024-03-22

MAGNETOM Terra; MAGNETOM Terra.X

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232322

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KCT 2024-03-22

BAHADIR STERILIZATION CONTAINERS

Applicant Bahadir USA, LLC

K-Number K233578

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OVE 2024-03-22

Idys® C ZP 3DTi

Applicant Clariance

K-Number K240715

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LZA 2024-03-22

Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

Applicant O&M Halyard, Inc.

K-Number K231938

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