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 2019-09-26

PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate

Applicant Shen Wei USA, Inc.

K-Number K190466

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NEU 2019-09-26

BioZorb SP Marker

Applicant Focal Therapeutics

K-Number K192371

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ODP 2019-09-26

eCarbon IBDs

Applicant Back 2 Basics Direct, LLC

K-Number K191537

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DRE 2019-09-26

Sterile Dilator

Applicant Galt Medical Corp.

K-Number K192195

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LZA 2019-09-26

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff

Applicant Hartalega NGC Sdn. Bhd.

K-Number K190454

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OBO 2019-09-26

Spectralis HRA+OCT and Variants

Applicant Heidelberg Engineering GmbH

K-Number K192391

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LLZ 2019-09-26

NuVasive NuvaLine

Applicant Nu Vasive, Incorporated

K-Number K192435

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KIF 2019-09-26

Dia-Proseal

Applicant DiaDent Group International

K-Number K182009

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MQL 2019-09-26

SepaSperm Washing Solution, SepaSperm Solution

Applicant Kitazato Corporation

K-Number K190199

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FTL 2019-09-26

Exogenesis Hernia Mesh

Applicant Exogenesis Corporation

K-Number K191545

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OUR 2019-09-26

Genesys Spine Sacroiliac Joint Fusion System

Applicant Genesys Spine

K-Number K191748

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KPR 2019-09-26

GXR-Series Diagnostic X-Ray System

Applicant DRGEM Corporation

K-Number K192364

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