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

DQK 2022-08-17

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

Applicant Biosense Webster, Inc.

K-Number K221112

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QRL 2022-08-17

Disposable Blood Lancets

Applicant Suzhou Kyuan Medical Apparatus Co., Ltd.

K-Number K220387

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QHE 2022-08-17

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K220452

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DQA 2022-08-16

YUWELL Finger Pulse Oximeter

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K-Number K212385

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LZA 2022-08-16

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Applicant O&M Halyard, Inc.

K-Number K213937

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LLZ 2022-08-16

syngo Application Software (VE21)

Applicant Siemens Medical Solution USA, Inc.

K-Number K220433

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IYN 2022-08-16

ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K221190

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GJS 2022-08-16

HemosIL ReadiPlasTin

Applicant Instrumentation Laboratory CO

K-Number K213426

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PPN 2022-08-16

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

Applicant Shockwave Medical, Inc.

K-Number K221852

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NXC 2022-08-16

Clear Aligner

Applicant Shenzhen Meiming Dentistry Technology Co., Ltd.

K-Number K213026

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EBF 2022-08-16

G-CAM

Applicant Graphenano Dental S.L.

K-Number K220329

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MBI 2022-08-16

FairFix Adjustable Button System

Applicant Medacta International S.A.

K-Number K222169

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