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

FJK 2017-06-16

DORA Tubing Sets for Hemodialysis

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K-Number K161582

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KWQ 2017-06-16

Cure™ Lumbar Plate System

Applicant Meditech Spine, LLC

K-Number K171538

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GAM 2017-06-16

Silhouette InstaLift

Applicant Silhouette Lift, Inc.

K-Number K163676

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HRS 2017-06-16

BioPro Foot Plating Systems

Applicant Biopro, Inc.

K-Number K162674

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OBJ 2017-06-15

AcuNav Diagnostic Ultrasound Catheter 8F,10F

Applicant Siemens Medical Solutions USA, Inc.

K-Number K170263

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LQJ 2017-06-15

Katalyst Cyclophotocoagulation Probe

Applicant Katalyst Surgical, LLC

K-Number K163632

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JWH 2017-06-15

ATTUNE Cemented Tibial Base, Fixed Bearing

Applicant Depuy(Ireland)

K-Number K170806

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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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