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

DXN 2024-03-15

Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)

Applicant Shenzhen Yuezhongxing Technology Co., Ltd.

K-Number K233799

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NKB 2024-03-15

Vital Spinal Fixation System

Applicant Zimvie Spine (Zimmer Biomet Spine, Inc.)

K-Number K240539

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DQK 2024-03-14

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

Applicant Philips Medical Systems Nederland B.V.

K-Number K233853

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NKG 2024-03-14

QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments

Applicant Globus Medical, Inc.

K-Number K231850

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PNP 2024-03-14

CloudPoint FastDesign Chairside

Applicant Prismatik Dentalcraft, Inc.

K-Number K231529

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ERL 2024-03-14

hekaDrill

Applicant Zethon, Ltd.

K-Number K233958

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QFX 2024-03-14

Myriad SPECTRA Light Source

Applicant Nico Corporation

K-Number K232567

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MQK 2024-03-14

SpermAlign Sperm Separation Device

Applicant Cytoswim, Ltd.

K-Number K232980

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GEI 2024-03-14

Define RF Microneedling System

Applicant Aesthetic Management Partners

K-Number K232301

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KDI 2024-03-14

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)

Applicant Nxstage Medical, Inc.

K-Number K232803

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OLO 2024-03-14

Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System

Applicant Stryker Leibinger GmbH & Co KG

K-Number K233542

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NAY 2024-03-14

da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation

Applicant Intuitive Surgical, Inc.

K-Number K232610

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