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

GEI 2022-10-17

WavelinQ Generator

Applicant C.R. Bard, Inc.

K-Number K222793

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OVD 2022-10-17

Standalone ALIF Interbody Fusion System

Applicant Eminent Spine

K-Number K221936

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LZA 2022-10-17

Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves

Applicant Zibo Langu New Material Technology Co., Ltd.

K-Number K222074

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QOI 2022-10-16

SafeBreak Vascular

Applicant Lineus Medical, LLC

K-Number K222791

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GEI 2022-10-16

LUDWIG Electrosurgical Device

Applicant Aesthetics Biomedical

K-Number K221574

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DQA 2022-10-16

Pulse Oximeter (Model C101A2, C101B1, C101A3)

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K-Number K221979

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BXN 2022-10-16

STIMPOD NMS450 Nerve Stimulator

Applicant Xavant Technology (Pty), Ltd.

K-Number K213049

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ODP 2022-10-15

CONDUIT Cages; FIBERGRAFT BG Putty

Applicant Depuy Spine

K-Number K222276

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NGX 2022-10-14

CoreLevee

Applicant Lutronic Corporation

K-Number K213748

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IPF 2022-10-14

Shoulder PacemakerTM

Applicant Ncs Lab Srl

K-Number K220994

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DQY 2022-10-14

Sublime Microcatheter

Applicant Surmodics,Inc.

K-Number K221886

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OHT 2022-10-14

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

Applicant Shenzhen Ishine Technology Company Limited

K-Number K222537

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