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

MQB 2016-12-01

CareView 750Cw/750C X-ray Flat Panel Detectors

Applicant Careray Digital Medical System Co., Ltd.

K-Number K163019

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IYE 2016-12-01

ClearCheck

Applicant Radformation

K-Number K162468

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GEI 2016-12-01

CODMAN Integrated Bipolar Cord and Tubing Set

Applicant Medos International SARL

K-Number K163106

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HBE 2016-12-01

Phasor Drill

Applicant Biotex, Inc.

K-Number K161704

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FZE 2016-12-01

Osseointegrated Fixtures

Applicant Southern Implants (Pty), Ltd.

K-Number K161548

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IPF 2016-12-01

CyMedica e-vive System; CY-1000

Applicant Cymedica Orthopedics, Inc.

K-Number K163067

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OVD 2016-12-01

SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device

Applicant SeaSpine Orthopedics Corporation

K-Number K162351

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NGX 2016-12-01

AK Body Toning Device

Applicant Ak Beauty Enterprises, LLC

K-Number K152420

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JIT 2016-12-01

Lumipulse G E2-III Calibrators

Applicant Fujirebio Diagnostics,Inc.

K-Number K163053

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MQN 2016-12-01

Internal Distraction - Sterile

Applicant KLS Martin L.P.

K-Number K161470

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PKP 2016-12-01

SCIg60 Infuser

Applicant Emed Technologies Corporation

K-Number K161906

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OMP 2016-12-01

WoundPro Negative Pressure Wound Therapy System

Applicant Pensar Medical, LLC

K-Number K150960

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