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

OAP 2023-06-14

F65 Laser System

Applicant Lumenis Be, Ltd.

K-Number K222790

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BZE 2023-06-14

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

Applicant Draegerwerk AG & CO Kgaa

K-Number K222822

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MUM 2023-06-14

Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K223067

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DXN 2023-06-14

Electronic Blood Pressure Monitor

Applicant Shenzhen Pango Medical Electronics Co., Ltd.

K-Number K223291

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JDS 2023-06-14

TRIGEN META-NAIL Nail System

Applicant Smith & Nephew, Inc.

K-Number K230761

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KDI 2023-06-14

ClearumTM HS

Applicant Bellco Srl

K-Number K231406

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FRA 2023-06-14

Synexis Sphere Rx

Applicant Synexis, LLC

K-Number K221540

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DZE 2023-06-14

IR SLA Type Implant System

Applicant Biotem Co., Ltd.

K-Number K222144

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OVD 2023-06-14

Zavation ALIF System

Applicant Zavation Medical Products, LLC

K-Number K230731

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EOB 2023-06-14

Single-use Flexible Rhinolaryngoscope; Digital Video Monitor

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K230536

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KWQ 2023-06-13

Axis Anterior Cervical Plate System

Applicant Southern Medical (Pty) , Ltd.

K-Number K231145

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NXC 2023-06-13

Clear Aligner

Applicant Wuxi EA Medical Instruments Technologies Limited.

K-Number K223517

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