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

KWT 2022-09-28

AGILON XO Shoulder System

Applicant Implantcast GmbH

K-Number K222482

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MED 2022-09-28

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

Applicant STERIS Corporation

K-Number K222615

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HIS 2022-09-28

TROJAN Fire & Ice lubricated male natural rubber latex condom

Applicant Church & Dwight Co., Inc.

K-Number K221906

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KNG 2022-09-28

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

Applicant Contec Medical Systems Co.,Ltd

K-Number K220245

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QAS 2022-09-28

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K222329

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KGN 2022-09-28

InnovaMatrix PD

Applicant Triad Life Sciences, Inc.

K-Number K211902

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LYZ 2022-09-28

DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)

Applicant Anhui Bytech Medical Supplies Co., Ltd.

K-Number K222442

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OTJ 2022-09-28

CORE-SPORT

Applicant Incore Co., Ltd.

K-Number K220081

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OHT 2022-09-28

IPL Hair Removal Device

Applicant Shenzhen Goodwind Technology Development Co., Ltd.

K-Number K222316

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DRT 2022-09-28

Neteera 130H/131H Vital Sign Monitoring Sensor

Applicant Neteera Technologies , Ltd.

K-Number K212143

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EFB 2022-09-28

Dental Air Polishing Handpiece

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K221548

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PSY 2022-09-27

NanoZoomer S360MD Slide scanner system

Applicant Hamamatsu Photonics K.K.

K-Number K213883

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