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

QTT 2022-08-30

SaliPen

Applicant Saliwell , Ltd.

K-Number K220618

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PHC 2022-08-30

Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K-Number K211124

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JKA 2022-08-30

SOL-GUARD Safety Pull Button Collection Set

Applicant Sol-Millennium Medical, Inc.

K-Number K213718

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FXX 2022-08-30

Medical Surgery Mask, Model:2626-7

Applicant Dongguan Missadola Technology Co., Ltd.

K-Number K220067

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DXN 2022-08-30

INDEX BPM

Applicant Ya Horng Electronic Co., Ltd.

K-Number K221486

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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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