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

HQF 2023-09-12

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

Applicant Meridian AG

K-Number K231011

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QTZ 2023-09-12

Ablation-fit

Applicant R.A.W. S.R.L

K-Number K222938

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KWQ 2023-09-12

Skyway Anterior Cervical Plate System

Applicant Kyocera Medical Technologies Inc. (KMTI)

K-Number K231766

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KPR 2023-09-12

Definium Pace Select

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K231892

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IYO 2023-09-12

Velacur

Applicant Sonic Incytes

K-Number K232459

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IYE 2023-09-12

TrueBeam, TrueBeam STx, Edge, VitalBeam

Applicant Varian Medical Systems, Inc.

K-Number K231317

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JAA 2023-09-12

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

Applicant Canon Medical Systems Corporation

K-Number K232526

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CCK 2023-09-12

Endure ETCO2/02 Nasal Cannula

Applicant Endure Industries, Inc.

K-Number K213767

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IYO 2023-09-11

SiteRite 9 Ultrasound System

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K-Number K231283

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MBI 2023-09-11

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)

Applicant Jarmon Medical, LLC (Dba Legends Orthopedics)

K-Number K230517

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CGA 2023-09-11

i-STAT G cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K223755

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HWC 2023-09-11

TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System

Applicant Vilex, LLC

K-Number K231504

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