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

OLO 2022-08-30

Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System

Applicant Brainlab AG

K-Number K221618

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JKA 2022-08-29

K-SHIELD Zen

Applicant Sb-Kawasumi Laboratories, Inc.

K-Number K220799

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LNH 2022-08-29

TCL3 Motion Tracking System

Applicant Tracinnovations A/S

K-Number K221785

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HKI 2022-08-29

Non-Mydriatic Retinal Camera NW500

Applicant Topcon Corporation

K-Number K221111

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NKB 2022-08-29

Salvo® Spine System

Applicant Spine Wave, Inc.

K-Number K222362

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EZC 2022-08-29

Rusch Intermittent Urethral Catheters

Applicant Teleflex Medical

K-Number K222279

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ILY 2022-08-29

OLIZ LTB-1000A

Applicant Ltbio Co., Ltd.

K-Number K221189

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QIH 2022-08-29

Viz RV/LV

Applicant Viz. Ai, Inc.

K-Number K221100

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FOZ 2022-08-29

Leaderflex Mini and Leaderflex Nano

Applicant Vygon USA

K-Number K212370

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NBW 2022-08-29

GlucoLeader Enhance 2 Blood Glucose Monitoring System

Applicant Hmd Biomedical, Inc.

K-Number K212248

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DXN 2022-08-29

Blood Pressure Monitor

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K220676

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LZC 2022-08-27

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K222449

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