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

QAS 2022-04-26

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K213886

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GZI 2022-04-25

MyoCycle MC-2 (Home / Home + / Pro / Pro +)

Applicant Myolyn, LLC

K-Number K213925

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PPN 2022-04-25

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System

Applicant Shockwave Medical, Inc.

K-Number K221041

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DQK 2022-04-25

CER-S

Applicant Cardiocalm Srl

K-Number K213861

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FXX 2022-04-25

Disposable Surgical Face Mask (M01, M02)

Applicant Fomed Industries, Inc.

K-Number K220512

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LYY 2022-04-24

Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves

Applicant Avecena Gloves Sdn Bhd

K-Number K213775

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LHI 2022-04-24

IVX Fluid Transfer Set

Applicant Omnicell, Inc.

K-Number K212530

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GZJ 2022-04-23

TENS device-EmeTerm 2, Model: YF-ZTY-E2

Applicant Wat Medical Technology, Inc.

K-Number K220503

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INI 2022-04-22

Electric Scooter

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K-Number K212090

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LLZ 2022-04-22

MirrorMe3D Modeling System

Applicant Mirrorme3D, LLC

K-Number K212981

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FRO 2022-04-22

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K211123

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BTT 2022-04-22

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K212031

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