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

PZI 2016-01-27

StatStrip Xpress 2 Glucose Hospital Meter System

Applicant Nova Biomedical Corporation

K-Number K152986

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NBL 2016-01-27

VistaCam iX Proof

Applicant Durr Dental AG

K-Number K150672

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LEJ 2016-01-27

BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

Applicant Sportarredo Group S.C.

K-Number K152233

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FZP 2016-01-27

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip

Applicant AtriCure, Inc.

K-Number K153500

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DQK 2016-01-27

Holter System

Applicant Edan Instruments, Inc.

K-Number K151787

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GYC 2016-01-27

Cervello STIM

Applicant Blackrock Neuromed

K-Number K151354

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DQY 2016-01-27

8F FlowGate2 Balloon Guide Catheter

Applicant Concentric Medical

K-Number K153729

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MQL 2016-01-27

Sydney IVF Hyaluronidase

Applicant William A. Cook Australia Pty. , Ltd.

K-Number K151367

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MQL 2016-01-27

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium

Applicant William A. Cook Australia Pty. , Ltd.

K-Number K153290

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GWQ 2016-01-26

Discovery 24

Applicant Brainmaster Technologies, Inc.

K-Number K150498

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DQY 2016-01-26

CenterCross Ultra Catheter

Applicant Roxwood Medical, Inc.

K-Number K152456

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HWC 2016-01-26

Tenodesis screw system

Applicant Normed Medizin-Technik GmbH

K-Number K151701

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