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

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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DQX 2023-10-28

Mighty Wire Guide Wire

Applicant Merit Medical Systems, Inc.

K-Number K230418

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QVJ 2023-10-27

Plaxpot Multi Plasma

Applicant Gcs Co. Limited

K-Number K220493

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KNS 2023-10-27

AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)

Applicant Boston Scientific Corporation

K-Number K233318

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CHL 2023-10-27

i-STAT CG8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K230285

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