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

FER 2024-12-13

Gastro Concepts Air Assist

Applicant Gastro Concepts, LLC

K-Number K242668

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MNT 2024-12-13

Vivo 3

Applicant Breas Medical AB

K-Number K240779

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OHT 2024-12-13

Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K241998

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NFO 2024-12-13

BTL-785BNF-E

Applicant BTL Industries, Inc.

K-Number K242532

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CBK 2024-12-13

731 Series Ventilator

Applicant ZOLL Medical Corporation

K-Number K233486

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ETN 2024-12-13

Bioscope Neuromonitor Device

Applicant Biosys Biyomedikal Muhendislik San. VE Tic. A.S.

K-Number K233001

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GCJ 2024-12-13

LCD Monitor (MDEC-2523)

Applicant Barco N.V.

K-Number K243307

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NXC 2024-12-12

GENIOVA aligners

Applicant Geniova Technologies Sociedad Limitada

K-Number K233152

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IYN 2024-12-12

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K242020

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KNS 2024-12-12

Aqua Medical RF Vapor Ablation System

Applicant Aqua Medical, Inc.

K-Number K241271

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KIF 2024-12-12

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)

Applicant Longly Biotechnology (Wuhan) Co., Ltd.

K-Number K242934

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EBD 2024-12-12

visio.lign color, visio.lign shield

Applicant Bredent GmbH & Co. KG

K-Number K240735

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