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

DZE 2021-08-27

PrimeTaper EV Dental Implant

Applicant Dentsply Sirona, Inc.

K-Number K210610

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NXC 2021-08-27

Clear Aligners

Applicant Shenzhen Yinuo Dental Technology Co.Ltd

K-Number K210373

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PGZ 2021-08-27

XSTAT 30 Pouch

Applicant Revmedx, Inc.

K-Number K210676

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BWK 2021-08-27

Needle Stimulator

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K-Number K202861

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KPS 2021-08-27

MyoSPECT, MyoSpect ES

Applicant GE Healthcare

K-Number K212004

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PND 2021-08-27

Stiletto Extended Dwell Catheter

Applicant Piper Access, LLC

K-Number K210047

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IYN 2021-08-27

LOGIQ E10s, LOGIQ Fortis

Applicant GE Healthcare

K-Number K211524

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PNR 2021-08-27

ENFit Reusable Enteral Syringe

Applicant Shantou Wealy Medical Instrument Co.,Ltd

K-Number K203613

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OLO 2021-08-27

Virage Navigation System

Applicant Zimmer Biomet Spine, Inc.

K-Number K212023

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GZF 2021-08-27

Neuspera Neurostimulation System (NNS)

Applicant Neuspera Medical, Inc.

K-Number K202781

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EOQ 2021-08-26

Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)

Applicant Intuitive Surgical, Inc.

K-Number K212048

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HGX 2021-08-26

TT Electric Breast Pump, TT Double Electric Breast Pump

Applicant Wuxi Xinzhongrui Baby Supplies Co., Ltd.

K-Number K202802

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