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

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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DQX 2024-05-24

PacePro Wire

Applicant Opsens, Inc.

K-Number K240864

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FRO 2024-05-24

ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC

Applicant Foshan United Medical Technologies, Ltd.

K-Number K233111

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DZE 2024-05-24

8plant Implant System

Applicant Hoowon Edi Co., Ltd.

K-Number K231426

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NHA 2024-05-24

KATANA Zirconia ONE For IMPLANT

Applicant Kuraray Noritake Dental, Inc.

K-Number K233285

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