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

HCG 2016-08-31

HydroCoil Embolic System (HES)

Applicant MicroVention, Inc.

K-Number K161367

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IYN 2016-08-31

Vscan Extend

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K161588

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NBW 2016-08-31

ACCU-CHEK Guide Blood Glucose Monitoring System

Applicant Roche Diabetes Care, Inc.

K-Number K160944

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LNH 2016-08-31

MAGiC

Applicant Ge Medical Systems, LLC

K-Number K161397

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MOS 2016-08-31

1.5T and 3.0T 16 CH GE Shoulder Coils

Applicant Invivo Corporation

K-Number K162001

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MEH 2016-08-31

Exactech® Novation® Element Press-fit Femoral Stem

Applicant Exactech, Inc.

K-Number K153649

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NUC 2016-08-31

Trojan Chain Reaction Personal Lubricant

Applicant Church & Dwight Co., Inc.

K-Number K161544

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HCG 2016-08-31

MicroPlex Coil System (MCS) - HyperSoft 3D

Applicant MicroVention, Inc.

K-Number K161452

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FEQ 2016-08-31

Erbes CO2 Tubing/Cap Sets

Applicant Erbe USA, Inc.

K-Number K162152

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KIF 2016-08-31

MTA Repair HP

Applicant Angelus Industria DE Productos Odontologicos

K-Number K151047

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OCW 2016-08-30

Miret Grasper, Alligator, Miret Grasper, Maryland

Applicant Miret Surgical, Inc.

K-Number K160149

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JAK 2016-08-30

OnSight 3D Extremity System

Applicant Carestream Health, Inc.

K-Number K160723

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