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

ONF 2022-09-21

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200

Applicant Shenzhen Ionka Medical Technology Co., Ltd.

K-Number K221214

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OLZ 2022-09-21

SomnoMetry

Applicant Neumetry Medical, Inc.

K-Number K221179

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LCX 2022-09-21

Clearblue ® Early Pregnancy Test

Applicant Spd Swiss Precision Diagnostics GmbH

K-Number K213379

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EZD 2022-09-21

SpeediCath Flex Set

Applicant Coloplast

K-Number K222059

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NUC 2022-09-20

JO CUMPLAY Personal Lubricant

Applicant CC Wellness, LLC

K-Number K221908

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HRS 2022-09-20

DePuy Synthes 3.5mm Intrapelvic Acetabular System

Applicant DePuy Synthes

K-Number K221809

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KGN 2022-09-20

LUOFUCON Collagen Wound Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K213598

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HWC 2022-09-20

Tandry Compression Screw System

Applicant Microware Precision Co., Ltd.

K-Number K220359

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FYA 2022-09-20

Disposable Surgical Gown UM-148

Applicant Unimax Medical Products Co., Ltd.

K-Number K221717

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FLE 2022-09-20

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120

Applicant Tuttnauer , Ltd.

K-Number K221227

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FXX 2022-09-20

Surgical Face Mask (Non-sterile)

Applicant Xiantao Junhui Plastic Products Co., Ltd.

K-Number K221976

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QJP 2022-09-20

Millipede 088 Access Catheter

Applicant Perfuze, Ltd.

K-Number K214048

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