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

KOI 2021-12-29

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM

Applicant Nihon Kohden Corporation

K-Number K213316

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JPA 2021-12-29

GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2

Applicant Accriva Diagnostics, Inc.

K-Number K202101

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LYY 2021-12-29

Goody Gloves, Wincare, TBG Gloves

Applicant Thai Rubber Gloves Co., Ltd.

K-Number K213073

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LLZ 2021-12-29

CONVIVO In Vivo Pathology Suite

Applicant Carl Zeiss Meditec, AG

K-Number K211156

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LPL 2021-12-28

Alcon (serafilcon A) soft contact lenses for daily wear

Applicant Alcon Laboratories, Inc.

K-Number K212806

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LZA 2021-12-28

ATM Glove

Applicant Phu Duc Huy Production Trading Services Corporation

K-Number K213016

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KCT 2021-12-28

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

Applicant K1 Medical, LLC

K-Number K213209

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QQV 2021-12-27

Colibri System

Applicant Copan Wasp Srl

K-Number K193138

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IYN 2021-12-27

Sonosite PX Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K213763

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KGO 2021-12-27

Sterile Latex Surgical Gloves Powder Free

Applicant Pentavest Holdings Sdn Bhd

K-Number K212848

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LZA 2021-12-27

Dermoaroma Disposable Nitrile Examination Glove

Applicant Chuzhou Harmony Gloves Medical Technology Co.,Ltd

K-Number K212716

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HWC 2021-12-25

R3ACT Stabilization System

Applicant Paragon 28, Inc.

K-Number K211770

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