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

DZE 2019-03-29

Reflect Implant System

Applicant Ids - Integrated Dental Systems

K-Number K180924

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LLZ 2019-03-29

Thoracic VCAR with GSI Pulmonary Perfusion

Applicant GE Medical Systems SCS

K-Number K183210

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MSS 2019-03-29

BL-Cart IOL Delivery Cartridge

Applicant Ast Products, Inc.

K-Number K182965

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LKF 2019-03-29

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter

Applicant Cook Incorporated

K-Number K181770

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DJG 2019-03-29

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

Applicant Advin Biotech, Inc.

K-Number K182123

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DQA 2019-03-29

Loop System

Applicant Spry Health, Inc.

K-Number K181352

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MXC 2019-03-29

Confirm Rx Insertable Cardiac Monitor

Applicant Abbott

K-Number K182981

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GZF 2019-03-29

Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

Applicant Boston Scientific Neuromodulation

K-Number K183579

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PBX 2019-03-29

BTL-084

Applicant BTL Industries, Inc.

K-Number K190023

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NHV 2019-03-29

Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand

Applicant Ecolab, Inc.

K-Number K182164

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GZB 2019-03-29

Freedom Spinal Cord Stimulator (SCS) System

Applicant Stimwave Technologies Incorporated

K-Number K182720

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MWI 2019-03-29

3880 MRI Patient Monitoring System

Applicant Iradimed Corporation

K-Number K180903

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