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

CAZ 2016-06-21

ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set

Applicant Teleflex, Inc.

K-Number K153652

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OXO 2016-06-21

OEC Elite MiniView

Applicant Ge Hangwei Medical Systems Co., Ltd.

K-Number K160131

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OLP 2016-06-21

Acne Light Therapy Wand

Applicant Zuko, Inc.

K-Number K160691

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LLZ 2016-06-21

Advanced Medical Imaging Software Suite (KSWVWR)

Applicant Keosys Sas

K-Number K160334

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DQX 2016-06-21

ASAHI Fielder XT-A, ASAHI Fielder XT-R

Applicant Asahi Intecc Co., Ltd.

K-Number K153106

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MWI 2016-06-21

Masimo Root Monitoring System and Accessories

Applicant Masimo Corporation

K-Number K153225

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DZE 2016-06-21

s-Clean Tapered II RBM Implant System

Applicant Dentis Co., Ltd.

K-Number K160213

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IYE 2016-06-21

Gold Anchor

Applicant Naslund Medical AB

K-Number K160209

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LLZ 2016-06-21

DBSWIN and VistaEasy Imaging Software

Applicant Duerr Dental AG

K-Number K161444

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FMW 2016-06-20

DermaTherapy Bed Linens

Applicant Precision Fabrics Group, Inc.

K-Number K152884

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GEI 2016-06-20

Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator

Applicant Bovie Medical Corporation

K-Number K161134

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EHD 2016-06-20

BI IMAGE-X EVOLUTION

Applicant Radiotecnologia Industrial S.A. DE C.V.

K-Number K160458

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