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 2016-04-11

TREFOIL System

Applicant Nobel Biocare AB

K-Number K152836

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MXD 2016-04-11

BioMonitor 2-AF, BioMonitor 2-S

Applicant Biotronik, Inc.

K-Number K152995

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DZE 2016-04-11

Noris Medical MBI Dental Implant System

Applicant Noris Medical , Ltd.

K-Number K153043

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DRF 2016-04-11

Map-it Diagnostic Mapping Catheters

Applicant Access Point Technologies Ep, Inc.

K-Number K160390

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DZE 2016-04-08

OneQ-SL s-Clean Implant System

Applicant Dentis Co., Ltd.

K-Number K153639

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LPL 2016-04-08

Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Applicant INTEROJO, Inc.

K-Number K153766

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MUJ 2016-04-08

RayStation

Applicant RaySearch Laboratories AB (PUBL)

K-Number K160093

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DZE 2016-04-08

Noris Medical Zygomatic Dental Implant System

Applicant Noris Medical , Ltd.

K-Number K151909

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NHV 2016-04-08

Nephros S100

Applicant Nephros, Inc.

K-Number K153084

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EFB 2016-04-08

430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece

Applicant Dentalez, Inc.

K-Number K153411

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OLY 2016-04-08

MagView BIOMAGNETOMETER SYSTEM

Applicant Tristan Technologies, Inc.

K-Number K152184

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KXT 2016-04-08

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

Applicant Roche Diagnostics

K-Number K153301

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