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

IYN 2022-05-06

HM70 EVO Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K220269

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FYA 2022-05-06

Medline Orbis Chemo Surgical Gown

Applicant Medline Industries, LP

K-Number K214108

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NJM 2022-05-06

Vatech Clismile

Applicant Rayence Co., Ltd.

K-Number K220689

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HGX 2022-05-06

Electric Breast Pump

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K-Number K212564

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NUH 2022-05-06

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

Applicant Dongguan Bohuikang Technology Co.,Ltd

K-Number K213788

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LLZ 2022-05-06

Segment 3DPrint

Applicant Medviso AB

K-Number K211966

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CDZ 2022-05-06

Elecsys Testosterone II

Applicant Roche Diagnostics

K-Number K211685

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DQA 2022-05-06

Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC

Applicant Covidien, LLC

K-Number K212555

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GCA 2022-05-06

SpyGlass Discover Balloon Dilation Catheter

Applicant Boston Scientific Corporation

K-Number K212582

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FGE 2022-05-06

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K211021

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NBW 2022-05-06

IWL2020 Blood Glucose Monitoring System

Applicant Roche Diabetes Care, Inc.

K-Number K203711

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GXY 2022-05-06

Disposable EEG cable

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K-Number K213884

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