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

NHA 2016-08-05

Burn-out Cylinder and Angled Screw Abutments

Applicant Dentium Co., Ltd.

K-Number K160483

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HEB 2016-08-05

Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl

Applicant First Quality Hygienic, Inc.

K-Number K161877

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NBW 2016-08-05

On Call Pro Blood Glucose Monitoring System

Applicant Acon Laboratories

K-Number K161867

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ELW 2016-08-05

Image Fast Set, Image Regular Set

Applicant Sybron Dental Specialties

K-Number K160097

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DQK 2016-08-05

EP-TRACER System

Applicant Cardio Tek, BV

K-Number K161245

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PBZ 2016-08-05

Triton System

Applicant Gauss Surgical, Inc.,

K-Number K160338

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IYN 2016-08-05

LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K161224

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IYN 2016-08-05

Vivid iq

Applicant Ge Medical Systems Ultrasound and Primary Care Diagnostics L

K-Number K161706

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MED 2016-08-05

SYSTEM 1E Liquid Chemical Sterilant Processing System

Applicant STERIS Corporation

K-Number K161683

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HAE 2016-08-04

Fehling-Punches

Applicant Fehling Instruments GmbH & Co. KG

K-Number K153243

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DQY 2016-08-04

SIDEKICK and USHER Support Catheters

Applicant Bard Peripheral Vascular, Inc.

K-Number K161986

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LZA 2016-08-04

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

Applicant Hartalega Sdn Bhd

K-Number K160560

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