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 2019-03-12

Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces

Applicant Bovie Medical Corporation

K-Number K183610

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HWC 2019-03-12

ActivOrtho Nitinol Compression Screw System

Applicant Activortho, Inc.

K-Number K181610

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LSR 2019-03-12

BioPlex 2200 Lyme Total

Applicant Bio-Rad Laboratories

K-Number K183446

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QFR 2019-03-12

Quantra Hemostasis Analyzer, QPlus Cartridge

Applicant Hemosonics, LLC

K-Number DEN180017

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LON 2019-03-12

VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

Applicant bioMerieux, Inc.

K-Number K183524

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HWC 2019-03-12

INnate Cannulated Screw System

Applicant Exsomed Corporation

K-Number K183603

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FMI 2019-03-12

Safety insulin needle for single use

Applicant Berpu Medical Technology Co., Ltd.

K-Number K181447

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GEI 2019-03-12

Caiman 5 Maryland

Applicant Aesculap, Inc.

K-Number K183180

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HTN 2019-03-12

Double ENDOBUTTON Fixation Device

Applicant Smith and Nephew, Inc.

K-Number K183232

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GGP 2019-03-12

CRYOcheck FVIII Inhibitor Kit

Applicant Precision Biologic, Inc.

K-Number K183440

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NGS 2019-03-12

Endotoxin Activity Assay (EAA)

Applicant Spectral Medical, Inc.

K-Number K183176

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DXN 2019-03-12

Microlife Digital Blood Pressure Monitor

Applicant Microlife Intellectual Property GmbH

K-Number K183469

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