Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

LPL 2016-05-17

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens

Applicant Smart Performer Corp. , Ltd.

K-Number K152657

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FMF 2016-05-17

SiO2 Coated syringe 3 ml

Applicant Sio2 Medical Products

K-Number K153553

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FDF 2016-05-17

Third Eye Panoramic Auxiliary Endoscopy System - Resposable

Applicant Avantis Medical Systems, Inc.

K-Number K160356

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HRS 2016-05-17

BIOFOAM Bone Wedge

Applicant Wrightmedicaltechnologyinc

K-Number K152062

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GEX 2016-05-17

PicoSure Workstation

Applicant Cynosure, Inc.

K-Number K160480

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HRS 2016-05-17

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

Applicant Gpc Medical, Ltd.

K-Number K153716

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JJX 2016-05-17

IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers

Applicant Immunodiagnostic Systems , Ltd.

K-Number K161082

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LPH 2016-05-17

Escalade Legend Acetabular Shell

Applicant Ortho Development Corporation

K-Number K161080

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POV 2016-05-16

Trak Male Fertility Testing System

Applicant Sandstone Diagnostics, Inc.

K-Number K153683

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PHX 2016-05-16

COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)

Applicant Biomet Manufacturing Corp

K-Number K152754

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OLO 2016-05-16

Aesculap OrthoPilot Next Generation

Applicant Aesculap Implant Systems, LLC

K-Number K153396

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GWF 2016-05-16

MagPro R20

Applicant Tonica Elektronik A/S

K-Number K160280

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