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

MRW 2016-08-04

FacetBRIDGE® System

Applicant Ldr Spine USA, Inc.

K-Number K161798

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FRO 2016-08-04

Microlyte Ag

Applicant Imbed Biosciences, Inc.

K-Number K153756

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NHX 2016-08-04

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

Applicant Axis-Shield Diagnostics Limited

K-Number K153551

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FIP 2016-08-04

MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis

Applicant Med-Tech Water Systems, Inc.

K-Number K153329

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EBF 2016-08-04

CAPO BULK FILL

Applicant Schuetz Dental GmbH

K-Number K152471

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MHX 2016-08-04

Surveyor S4 Mobile Monitor

Applicant Mortara Instrument, Inc.

K-Number K160685

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FRG 2016-08-04

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

Applicant Safe Secure Packaging Co., Ltd.

K-Number K153540

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ONF 2016-08-04

IPL Therapy Machine

Applicant Beijing Adss Development Co., Ltd.

K-Number K161286

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OMP 2016-08-04

RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply

Applicant Smith & Nephew Medical, Ltd.

K-Number K153209

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LZA 2016-08-03

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

Applicant Kossan International Sdn Bhd

K-Number K151750

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KRD 2016-08-03

Hilal Embolization MicroCoils

Applicant Cook Incorporated

K-Number K160219

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NPM 2016-08-03

A-Oss

Applicant Hiossen, Inc.

K-Number K151542

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