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

OHS 2023-09-23

B.Light Clear Evo and B.Light Restore Evo

Applicant Bemer Int AG

K-Number K223919

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LJS 2023-09-22

CATHTONG™ II PICC Catheter

Applicant L&Z Us, Inc.

K-Number K232571

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LLZ 2023-09-22

Jazz

Applicant Ai Medical AG

K-Number K223659

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QAS 2023-09-22

Annalise Enterprise CTB Triage Trauma

Applicant Annalise-Ai Pty , Ltd.

K-Number K231767

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FOZ 2023-09-22

Nexiva™ Closed IV Catheter System with NearPort™ IV Access

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K231239

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NKB 2023-09-22

TriALTIS Spine System

Applicant Medos International SARL

K-Number K231479

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KLE 2023-09-22

DX. Bond V Dental Bonding Adhesive

Applicant Sino-Dentex Co., Ltd.

K-Number K232978

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ITI 2023-09-22

Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)

Applicant Yurob Rehabilitation Medical Co., Ltd.

K-Number K232193

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OHT 2023-09-22

IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10

Applicant Shenzhen Koli Technology Co.,Ltd

K-Number K232183

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QIH 2023-09-22

qXR-CTR

Applicant Qure.Ai Technologies

K-Number K231149

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EFB 2023-09-22

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors

Applicant Foshan Coxo Medical Instrument Co., Ltd.

K-Number K220179

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NUV 2023-09-22

T-SHAPE 2

Applicant B&M S.R.L. Marketing Nel Benessere

K-Number K231092

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