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

GEX 2024-06-12

Picosecond Nd:YAG Laser System; PICO LEGEND

Applicant Ami, Inc.

K-Number K233007

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JOJ 2024-06-12

EO Chex Indicator Tape

Applicant Propper Manufacturing Co., Inc.

K-Number K240910

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IYN 2024-06-12

ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K233610

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NGZ 2024-06-12

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

Applicant bioMerieux, Inc.

K-Number K232967

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FMF 2024-06-12

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

Applicant Perfect Medical Industry (Vn) Co., Ltd.

K-Number K232950

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DPS 2024-06-12

MEDIBLU ECG SYSTEM

Applicant Mediblu Medical, LLC

K-Number K233266

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IYN 2024-06-12

RS85 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K240516

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FAS 2024-06-12

PLASMA EDGE System

Applicant Lamidey Noury Medical

K-Number K240504

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JOJ 2024-06-11

MetriCide™ OPA Plus Solution Test Strip

Applicant Steris

K-Number K241344

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LIT 2024-06-11

JADE PLUS PTA Balloon Dilatation Catheter

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K241025

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OLO 2024-06-11

Mako Total Knee Application

Applicant Mako Surgical Corp.

K-Number K241011

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PCC 2024-06-11

DOOPANG

Applicant Ybrain, Inc.

K-Number K232749

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