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

DQY 2024-05-28

React 71 Catheter

Applicant Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

K-Number K241177

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GEX 2024-05-28

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)

Applicant Theralaser Medtech (China) Co., Ltd.

K-Number K240874

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MAX 2024-05-28

PILLAR SA Ti Spacer System (82-XXX)

Applicant Orthofix, Inc.

K-Number K240749

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DPT 2024-05-28

Laser Speckle Imaging System (RFLSI CZW)

Applicant Rwd Life Science Co., Ltd.

K-Number K233076

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NAY 2024-05-24

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)

Applicant Intuitive Surgical

K-Number K240723

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HRS 2024-05-24

NeoSpan® Compression Implant System

Applicant In2bones USA, LLC

K-Number K233089

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OBP 2024-05-24

Apollo TMS Therapy System

Applicant Mag & More GmbH

K-Number K232639

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FRG 2024-05-24

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Applicant Primed Medical Products, Inc.

K-Number K233777

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GCJ 2024-05-24

Monik - Disposable Endoscopic Trocar

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K233386

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OUO 2024-05-24

uPMR 790

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K234154

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GXD 2024-05-24

Racz Neurostat RF Generator

Applicant Epimed International

K-Number K232632

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DWA 2024-05-24

INSPIRA ART100

Applicant Inspira Technologies Oxy B.H.N. , Ltd.

K-Number K232788

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