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

QAS 2023-10-30

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K232751

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NDN 2023-10-30

Renova Spine Balloon Catheter

Applicant Biopsybell S.R.L.

K-Number K231340

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OBO 2023-10-30

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

Applicant Topcon Corporation

K-Number K231222

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LZA 2023-10-30

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl

Applicant Zhonghong Pulin Medical Products Co., Ltd.

K-Number K231029

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PLP 2023-10-30

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0

Applicant Insightec, Ltd.

K-Number K231378

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NHA 2023-10-30

AOT & T-L Abutment

Applicant Truabutment, Inc.

K-Number K231874

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IYN 2023-10-30

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232145

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PBX 2023-10-30

NuEra Tight RF Model OptiStream

Applicant Bios S.R.L.

K-Number K230755

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ODP 2023-10-30

ClariVy™ Cervical IBF System

Applicant Vy Spine, LLC

K-Number K231836

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IYN 2023-10-30

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K231965

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SBF 2023-10-29

NextAR™ TSA Platform

Applicant Medacta International S.A.

K-Number K232280

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OBJ 2023-10-28

AcuNav Crystal Ultrasound Catheter

Applicant Siemens Medical Solutions USA, Inc.

K-Number K233270

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