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

DSH 2023-09-25

Holter ECG and ABP System

Applicant Edan Instruments, Inc.

K-Number K230184

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NBC 2023-09-24

ADVIA Centaur® NT-proBNPII (PBNPII)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K220265

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DZE 2023-09-23

Osstem Implant System

Applicant Osstem Implant Co., Ltd.

K-Number K222778

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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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