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

HWC 2017-08-07

FuzeFix Screw System

Applicant Fusion Orthopedics, LLC

K-Number K170038

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OHS 2017-08-07

dpl SpectraLite

Applicant Led Technologies, Inc.

K-Number K171386

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GEX 2017-08-07

InMode Diolaze XL

Applicant Inmode MD , Ltd.

K-Number K170738

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FMF 2017-08-07

Merit Syringe

Applicant Merit Medical Systems, Inc.

K-Number K171362

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EBF 2017-08-04

REVEAL Bulk

Applicant Bisco, Inc.

K-Number K171147

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NDC 2017-08-04

Glucommander

Applicant Glytec, LLC

K-Number K152300

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NUH 2017-08-04

Hi-Dow Wireless TENS/EMS System (Model HD-5N)

Applicant Hi-Dow International, Inc.

K-Number K163393

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GZF 2017-08-04

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

Applicant Stimwave Technologies Inc., Dba Stimq, LLC

K-Number K171366

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OWN 2017-08-04

Cellvizio 100 Series Systems with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K171345

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EIH 2017-08-04

Life Essence Universal Porcelain System

Applicant Blue Sky Bio

K-Number K163251

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FCG 2017-08-04

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle

Applicant Wilson-Cook Medical, Inc.

K-Number K171596

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DZE 2017-08-04

Nucleoss Tpure Implant System

Applicant Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti

K-Number K160850

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