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

NKB 2016-09-08

SeaSpine® NewPort™ Spinal System

Applicant SeaSpine Orthopedics Corporation

K-Number K161535

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MBB 2016-09-08

StageOne Select Cement Spacer Molds for Temporary Hip Replacement

Applicant Biomet, Inc.

K-Number K161166

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KWH 2016-09-08

RTS Flexible 1 MPJ Implant w/Grommets

Applicant In2bones USA, LLC

K-Number K153609

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PHM 2016-09-08

Battalion Universal Spacer System

Applicant Alphatec Spine

K-Number K160958

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OVD 2016-09-08

PILLAR SA PTC

Applicant Orthofix, Inc.

K-Number K161129

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PGY 2016-09-08

2MP Color LCD Monitor CCL214 (CL21214)

Applicant Jvckenwood Corporation

K-Number K161895

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NPK 2016-09-08

Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm

Applicant Salvin Dental Specialties

K-Number K160493

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IYN 2016-09-08

SonoSite iViz Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K162288

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FOZ 2016-09-08

BioFlo Midline Catheter

Applicant Navilyst Medical, Inc.

K-Number K161866

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DZE 2016-09-08

BBX1, BBX2, BBX1MO, BBX1MC

Applicant Globaldental, Inc.

K-Number K142846

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MQB 2016-09-08

PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector

Applicant Perkinelmer, Inc.

K-Number K161966

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BZD 2016-09-08

Luna CPAP and Auto CPAP System

Applicant 3B Medical, Inc.

K-Number K153387

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