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

PGY 2024-03-29

LCD Monitors C310S, G310S, C316S, G316S, C616W

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K240310

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QIH 2024-03-29

AVIEW CAC

Applicant Coreline Soft Co., Ltd.

K-Number K233211

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IYE 2024-03-29

LUNA 3D

Applicant Lap GmbH Laser Applikationen

K-Number K232031

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FRN 2024-03-29

Novum IQ Large Volume Pump

Applicant Baxter Healthcare Corporation

K-Number K211122

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OLO 2024-03-29

Genesys Spine Sacroiliac Joint Fusion System with Navigation

Applicant Genesys Spine

K-Number K233595

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IYE 2024-03-29

AlignRT Plus

Applicant Vision Rt, Ltd.

K-Number K233622

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FYA 2024-03-29

Disposable Surgical Gown

Applicant Nanning Tecbod Biological Technology Co., Ltd.

K-Number K233068

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GXN 2024-03-28

CustomizedBone Service

Applicant Fin-Ceramica Faenza S.P.A.

K-Number K240567

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JAK 2024-03-28

NAEOTOM Alpha

Applicant Siemens Medical Solutions USA, Inc.

K-Number K233657

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ONB 2024-03-28

ProSeal™ Injector Plus (Model no. 421050)

Applicant Epic Medical Pte. , Ltd.

K-Number K240171

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NGL 2024-03-28

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)

Applicant Instanosis, Inc.

K-Number K240295

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GEI 2024-03-28

BTL-785S

Applicant BTL Industries, Inc.

K-Number K233604

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