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

DZE 2024-11-15

NUVENTUS NV.C™ Dental Implant System

Applicant Infinitum Eta, Ltd.

K-Number K233081

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QRL 2024-11-15

Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K243306

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OTM 2024-11-15

AdVance™ XP Male Sling System (720163-03)

Applicant Boston Scientific Corporation

K-Number K242960

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NLH 2024-11-15

Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

Applicant Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K-Number K241224

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QFM 2024-11-15

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

Applicant Vuno, Inc.

K-Number K241439

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QOF 2024-11-15

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

Applicant Hologic, Inc.

K-Number K242465

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MQE 2024-11-15

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

Applicant Shenzhen Vitavitro Biotech Co., Ltd.

K-Number K240523

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POK 2024-11-15

Koios DS

Applicant Koios Medical, Inc.

K-Number K242130

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IYN 2024-11-15

The 5000 Compact Series Ultrasound Systems

Applicant Philips Ultrasound, LLC

K-Number K242800

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LZO 2024-11-15

b-ONE® Total Hip System

Applicant B-One Ortho, Corp.

K-Number K240528

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OLO 2024-11-15

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K243285

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IYN 2024-11-15

ACUSON Redwood Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K243299

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