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

KPS 2016-01-21

Discovery NM/CT 670 CZT

Applicant GE Healthcare

K-Number K153402

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BZD 2016-01-21

DeVilbiss DV6WM Wireless Modem

Applicant Devilbiss Healthcare, LLC

K-Number K152810

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FRO 2016-01-21

AQUACEL Ag Surgical SP Dressing

Applicant Convatec Limited

K-Number K152926

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HRS 2016-01-21

aap LOQTEQ VA Radius Set 2.5

Applicant Aap Implantate AG

K-Number K153034

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BTY 2016-01-21

Shape-HF Cardiopulmonary Testing System

Applicant Shape Medical Systems, Inc.

K-Number K150888

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MAX 2016-01-21

Biomet Spine Fusion System

Applicant Biomet Spine, LLC

K-Number K153695

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BSZ 2016-01-21

Carestation 620/650/650C

Applicant Datex-Ohmeda, Inc.

K-Number K151570

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OCZ 2016-01-21

Grasping Forceps

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K152802

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IYN 2016-01-21

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS

Applicant Hitachi Aloka Medical America, Inc.

K-Number K153421

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MJN 2016-01-21

Pruitt F3-S Polyurethane Carotid Shunt

Applicant LeMaitre Vascular, Inc.

K-Number K152833

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BZE 2016-01-21

AirLife Infant Heated Wire Circuit

Applicant Care Fusion

K-Number K151303

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ITI 2016-01-21

Cajun Commando 4x4

Applicant Lil Critter, LLC

K-Number K152672

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