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

EBI 2023-10-20

NextDent Base

Applicant Vertex-Dental B.V.

K-Number K231388

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FDF 2023-10-20

Pure-Vu EVS System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K232922

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KPI 2023-10-20

Unicare (K-UNICARE-USA)

Applicant Tenscare, Ltd.

K-Number K230983

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KGO 2023-10-20

GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

Applicant Ansell Healthcare

K-Number K231902

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EBI 2023-10-20

Lucitone Digital Print Denture System

Applicant Dentsply Sirona

K-Number K231578

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LZA 2023-10-20

Nitrile Examination Gloves, Dual Color Black-Blue

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K232550

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MLR 2023-10-20

V-PRO maX 2 Low Temperature Sterilization System

Applicant Steris

K-Number K233065

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GEX 2023-10-20

Echo

Applicant Quanta System Spa

K-Number K232236

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GCJ 2023-10-20

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);

Applicant Mediconcepts Technology (Shenzhen) Company Limited

K-Number K232042

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MUH 2023-10-20

Digital Wireless Intraoral X-Ray Sensor

Applicant Iray Imaging Technology (Haining) Limited

K-Number K230998

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PML 2023-10-20

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement

Applicant Ulrich Medical USA

K-Number K231809

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ODC 2023-10-20

BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)

Applicant Steris

K-Number K232951

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