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

KFM 2023-10-26

Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)

Applicant Qura S.R.L

K-Number K233091

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NEU 2023-10-26

MOLLI 2

Applicant Molli Surgical, Inc.

K-Number K231579

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PFW 2023-10-25

sam CS Long Duration Ultrasound Device

Applicant ZetrOZ Systems, LLC

K-Number K233210

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GEI 2023-10-25

VVR Generator system

Applicant Starmed Co., Ltd.

K-Number K222997

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GEI 2023-10-25

PiXel8-RF

Applicant Rohrer Aesthetics

K-Number K233147

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KPR 2023-10-25

AcuityUDR

Applicant Radmedix, LLC

K-Number K231995

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JWH 2023-10-25

Balanced Knee® System TriMax PS Plus Tibial Insert

Applicant Ortho Development Corporation

K-Number K233093

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QAS 2023-10-25

Rapid SDH

Applicant Ischemaview, Inc.

K-Number K232436

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DZE 2023-10-25

UNIdental Symphony Implant System

Applicant Unidental Co., Ltd.

K-Number K221315

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PBF 2023-10-25

Newclip Patient-matched instrumentation non sterile PSI

Applicant Newclip Technics

K-Number K221615

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GEI 2023-10-25

POWERSEAL Sealer and Divider

Applicant Gyrus Acmi, Inc.

K-Number K231327

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HCG 2023-10-25

Penumbra LP Coil System

Applicant Penumbra, Inc.

K-Number K230284

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