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

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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NFJ 2022-08-15

FORUM

Applicant Carl Zeiss Meditec, AG

K-Number K213527

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GEX 2022-08-15

XLase Plus

Applicant Biotec Italia, Srl

K-Number K212790

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NJW 2022-08-15

Her-2, ER, PR IHControls

Applicant Boston Cell Standards, Inc.

K-Number K220163

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DSY 2022-08-15

HeRO Graft

Applicant Merit Medical Systems, Inc.

K-Number K213845

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