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

NFO 2024-12-19

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

Applicant Shenzhen Aozemei Technology Co., Ltd.

K-Number K243430

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BYI 2024-12-19

LibAirty Airway Clearance System

Applicant Synchrony Medical , Ltd.

K-Number K242063

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SDO 2024-12-19

ARC-EX System

Applicant Onward Medical, Inc.

K-Number DEN240014

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KGN 2024-12-19

Bovine Dermis Collagen Dermal Matrix

Applicant Collagen Matrix, Inc.

K-Number K243071

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MQB 2024-12-19

Yushan X-Ray Flat Panel Detector

Applicant Innocare Optoelectronics Corp.

K-Number K243171

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FTC 2024-12-19

UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)

Applicant Shanghai Sigma High-Tech Co., Ltd.

K-Number K242908

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HGX 2024-12-19

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)

Applicant Joytech Healthcare Co. , Ltd.

K-Number K241322

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PQA 2024-12-19

BD Vaginal Panel

Applicant Becton, Dickinson and Company

K-Number K243725

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BTT 2024-12-19

Hudson RCI Comfort Flo® CubCannula

Applicant Medline Industries, LP

K-Number K241778

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PNR 2024-12-19

Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE)

Applicant Cardinalhealth

K-Number K243652

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FPD 2024-12-19

Nutrifit

Applicant Vygon USA

K-Number K243361

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MQL 2024-12-18

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

Applicant Artsmedia Denmark Aps

K-Number K241132

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