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

OWB 2017-10-24

Dynamic Coronary Roadmap 2.0

Applicant Philips Medical Systems Nederland B.V.

K-Number K172307

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LPH 2017-10-24

UTS Stem

Applicant United Orthopedic Corporation

K-Number K172251

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KWQ 2017-10-23

Liberty Anterior Cervical Plate

Applicant Valorus Spine

K-Number K172585

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NFO 2017-10-23

BeneLife Premium Facial Treatment Pack, Model: QZ0701A

Applicant Infinitus (China) Company , Ltd.

K-Number K171647

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LYZ 2017-10-23

STERILE VINYL EXAMINATION GLOVES, Powder Free

Applicant Primus Gloves Pvt Limited

K-Number K170612

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LSR 2017-10-23

Lyme B. burgdorferi (IgM) MarStripe Test

Applicant Trinity Biotech

K-Number K172254

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HWC 2017-10-23

MECRON Cannulated Screw System

Applicant Merete GmbH

K-Number K172213

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JWY 2017-10-23

Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.

Applicant Liofilchem s.r.l.

K-Number K172542

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OOU 2017-10-23

Panther Fusion Paraflu Assay

Applicant Hologic, Inc.

K-Number K172282

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GAM 2017-10-23

Monosyn Quick Synthetic Absorbable Surgical Suture

Applicant Aesculap, Inc.

K-Number K171001

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HWC 2017-10-23

IRENE Cannulated Screw System

Applicant Tianjin Zhengtian Medical Instrument Co., Ltd.

K-Number K170056

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MAX 2017-10-23

Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology

Applicant Rti Surgical, Inc.

K-Number K172343

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