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

EBI 2022-09-21

V-Print dentbase

Applicant Voco GmbH

K-Number K220236

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PCH 2022-09-21

BD MAX Enteric Viral Panel

Applicant Becton, Dickinson and Company

K-Number K220607

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OTN 2022-09-21

ArcSP Suprapubic Sling System

Applicant Urocure, LLC

K-Number K222293

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OMP 2022-09-21

PWD Negative Pressure Wound Therapy System

Applicant Applied Tissue Technologies, LLC

K-Number K212359

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DQX 2022-09-21

EpiFaith CV

Applicant Flat Medical Co., Ltd.

K-Number K212615

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QRK 2022-09-21

MedtFine Blood Lancet

Applicant Shanghai Carelife International Trading Co. , Ltd.

K-Number K221383

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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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