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

LZA 2021-08-01

H2H Powder Free Examination Blue Glove

Applicant Ntl Innovation Co., Ltd.

K-Number K211182

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GEX 2021-07-30

UltraLase Flexible CO2 Laser Waveguide

Applicant W & R Investments, LLC Dba Laser Engineering

K-Number K211761

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LJS 2021-07-30

BD PowerPiCC Catheter

Applicant Bard Access Systems, Inc.

K-Number K210264

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IYO 2021-07-30

FibroScan 230

Applicant Echosens

K-Number K212035

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PBX 2021-07-30

Sectum

Applicant Neauvia North America

K-Number K202780

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IPF 2021-07-30

PowerDot PD-01MT2 Muscle Stimulator

Applicant Smartmissimo Technologies Pte, Ltd.

K-Number K210938

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NKG 2021-07-30

Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K-Number K211710

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PKT 2021-07-30

Powersculp laser lipolysis system

Applicant Lotuxs Medtech (Suzhou) Co., Ltd.

K-Number K211402

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JTN 2021-07-30

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K-Number K203700

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IYN 2021-07-30

Labat series Diagnostic Ultrasound System

Applicant Shenzhen Wisonic Medical Technology Co. , Ltd.

K-Number K210154

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GCJ 2021-07-30

Lab Bag with Fabric Pouch

Applicant Advanced Medical Design Co., Ltd.

K-Number K210248

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QAQ 2021-07-30

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

Applicant Edwards Lifesciences, LLC

K-Number K203224

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