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

DXO 2016-09-13

OptoMonitor II

Applicant Opsens, Inc.

K-Number K161263

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PBX 2016-09-13

TR-100

Applicant BTL Industries, Inc.

K-Number K161551

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EIH 2016-09-13

Initial LiSi Block

Applicant GC America, Inc.

K-Number K153130

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MAX 2016-09-12

JULIET® LL Lateral Lumbar Cage

Applicant Spineart

K-Number K161888

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EIH 2016-09-12

Pavati Z40.2 Zirconia

Applicant Ccri, Inc.

K-Number K160867

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PBX 2016-09-12

Profound System

Applicant Syneron Candela Corporation

K-Number K161043

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DZE 2016-09-12

Implance Dental Implant System, Implance Dental Abutment System

Applicant Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.

K-Number K160221

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OBP 2016-09-11

NeuroStar TMS Therapy System

Applicant Neuronetics, Inc.

K-Number K161519

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EOB 2016-09-09

ULYSS Multi View Sinuscope

Applicant Sopro-Comeg GmbH

K-Number K153701

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OCW 2016-09-09

AbClose - Port Site Closure Device

Applicant Medeon Biodesign, Inc.

K-Number K160117

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LZA 2016-09-09

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K161187

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GEI 2016-09-09

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

Applicant Venclose, Inc.

K-Number K160754

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