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

DXN 2016-06-01

EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform

Applicant Edwards Lifesciences, LLC

K-Number K160552

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JOJ 2016-06-01

VERIFY VH2O2 Indicator Tape

Applicant STERIS Corporation

K-Number K160485

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KPS 2016-06-01

Hermes Medical Imaging Suite v5.6

Applicant Hermes Medical Solutions AB

K-Number K153056

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PIG 2016-06-01

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

Applicant Astute Medical, Inc.

K-Number K153165

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LHQ 2016-06-01

FirstSense Breast Exam

Applicant First Sense Medical, LLC

K-Number K160573

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KLC 2016-06-01

DCI Edge Dental Chair with Operative Unit

Applicant Dci

K-Number K151987

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GEI 2016-06-01

Voyant Open Fusion Device

Applicant Applied Medical Resources

K-Number K153288

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FRG 2016-06-01

Gemini Bonded Sterilization Wrap

Applicant Medline Industries, Inc.

K-Number K152458

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HTY 2016-06-01

Additive Orthopaedics Hammertoe Correction System

Applicant Additive Orthopaedics, LLC

K-Number K160264

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GAP 2016-05-31

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K160623

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GDW 2016-05-31

CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners

Applicant C.R. Bard, Inc.

K-Number K160900

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JLW 2016-05-31

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K160647

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