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

ODC 2024-03-15

Endorail

Applicant Endostart S.R.L.

K-Number K232327

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ONF 2024-03-15

Intensity Pulsed Light Therapy System

Applicant Beijing Adss Development Co., Ltd.

K-Number K233307

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MAI 2024-03-15

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw

Applicant Depuy Mitek

K-Number K240441

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QNQ 2024-03-15

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))

Applicant Medexel Co.,Ltd

K-Number K231856

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QSY 2024-03-15

RESPONDER® Polysaccharide Hemostat

Applicant Starch Medical, Inc.

K-Number K240454

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OAN 2024-03-15

STARband 3D

Applicant Orthomerica Products, Inc.

K-Number K240466

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EBF 2024-03-15

FORMA Composite (Shade A3D)

Applicant Ultradent Products, Inc.

K-Number K240694

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GJS 2024-03-15

Xprecia Prime Coagulation System

Applicant Universal Biosensors Pty, Ltd.

K-Number K230802

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EWO 2024-03-15

Otoport Pro

Applicant Otodynamics, Ltd.

K-Number K240430

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DXN 2024-03-15

Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)

Applicant Shenzhen Yuezhongxing Technology Co., Ltd.

K-Number K233799

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NKB 2024-03-15

Vital™ Spinal Fixation System

Applicant Zimvie Spine (Zimmer Biomet Spine, Inc.)

K-Number K240539

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DQK 2024-03-14

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

Applicant Philips Medical Systems Nederland B.V.

K-Number K233853

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