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

MBH 2017-06-15

BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell

Applicant Microport Orthopedics, Inc.

K-Number K170288

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OQO 2017-06-15

Aptima Herpes Simplex Viruses 1 & 2 Assay

Applicant Hologic, Inc.

K-Number K162673

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FDS 2017-06-15

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K162749

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DZE 2017-06-15

Axiom PX

Applicant Anthogyr Sas

K-Number K161177

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OBJ 2017-06-15

AcuNav V 10F Ultrasound Catheter

Applicant Siemens Medical Solutions USA, Inc.

K-Number K170992

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OVE 2017-06-15

SeaSpine Shoreline ACS - Anterior Cervical Standalone System

Applicant SeaSpine Orthopedics Corporation

K-Number K170569

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FPA 2017-06-15

Encore Neutral

Applicant Rymed Technologies, LLC

K-Number K162826

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GAM 2017-06-15

TroClose1200, TroClose1200 Cannula

Applicant Gordian Surgical, Ltd.

K-Number K171494

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KGO 2017-06-15

Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)

Applicant Cardinal Health, Inc.

K-Number K170198

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PAY 2017-06-15

sensiLift

Applicant El Global Trade, Ltd.

K-Number K170499

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DXT 2017-06-15

Merit Coronary Control Syringe

Applicant Merit Medical Systems, Inc.

K-Number K163084

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NEU 2017-06-15

HydroMARK Breast Biopsy Site Markers

Applicant Devicor Medical Products, Inc.

K-Number K170803

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