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

JXG 2016-03-04

Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory

Applicant Integra LifeSciences Corporation

K-Number K152897

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LLZ 2016-03-04

syngo Application Software VD11

Applicant Siemens Medical Solutions USA, Inc.

K-Number K153346

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CAF 2016-03-04

Propeller Sensor Model 2014-R

Applicant Reciprocal Labs

K-Number K152482

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FLE 2016-03-04

Family of Steam Sterilizers B 28 series

Applicant Cefla S.C.

K-Number K151597

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GZL 2016-03-04

DNAP Electrode

Applicant Ad-Tech Medical Instrument Corporation

K-Number K152547

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JAA 2016-03-04

Platinum dRF Imaging System

Applicant Apelem-Dms Group

K-Number K160301

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DQY 2016-03-04

MultiCross Catheter

Applicant Roxwood Medical, Inc.

K-Number K152957

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NAY 2016-03-04

IS4000 Stapler 30 Instrument and Stapler 30 Reloads

Applicant Intuitive Surgical, Inc.

K-Number K152421

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GKP 2016-03-03

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)

Applicant Instrumentation Laboratory CO

K-Number K160276

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PEM 2016-03-03

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

Applicant Pac-Dent International, Inc.

K-Number K151123

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EBI 2016-03-03

GC Reline II

Applicant GC America, Inc.

K-Number K153253

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LLZ 2016-03-03

Olea Sphere V3.0

Applicant Olea Medical

K-Number K152602

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