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

KGN 2024-10-18

ABCcolla® Collagen ADM Scaffold

Applicant Acro Biomedical Co., Ltd.

K-Number K233378

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HSN 2024-10-18

Kinos Total Ankle System

Applicant Restor3D

K-Number K242868

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FRC 2024-10-18

3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)

Applicant 3M Company

K-Number K241959

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GEH 2024-10-18

IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)

Applicant Boston Scientific Corp

K-Number K243245

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MOS 2024-10-18

dS Knee Coil 8ch 1.5T

Applicant Philips Medical Systems Nederland B.V.

K-Number K242879

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NUH 2024-10-18

Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator

Applicant Well-Life Healthcare Limited

K-Number K233054

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QHE 2024-10-18

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K242813

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QKB 2024-10-18

Contour+ (MVision AI Segmentation)

Applicant Mvision AI OY

K-Number K241490

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KGN 2024-10-18

Corplex P/ Theracor P/ Allacor P

Applicant Stimlabs, LLC

K-Number K242828

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MQV 2024-10-18

Mg OSTEOREVIVE, Mg OSTEOCRETE

Applicant Bone Solutions, Inc.

K-Number K242372

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FXX 2024-10-18

Surgical Face Mask (Tie on/ Ear loops)

Applicant Xiantao Daoqi Plastic Co., Ltd.

K-Number K240916

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NHA 2024-10-18

PreXolid CAD/CAM abutments

Applicant Eclectic Co., Ltd.

K-Number K240725

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