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

NEZ 2017-03-10

AdvanCE capsule endoscope delivery device

Applicant United States Endoscopy Group, Inc.

K-Number K163495

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JAQ 2017-03-10

Interstitial Needles

Applicant Varian Medical Systems, Inc.

K-Number K160815

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ERL 2017-03-09

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider

Applicant Laurimed, LLC

K-Number K163247

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DXZ 2017-03-09

PhotoFix Decellularized Bovine Pericardium

Applicant Cryolife, Inc.

K-Number K162506

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MUH 2017-03-09

JAZZ SOLO Sensor

Applicant Jazz Imaging, LLC

K-Number K163224

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NKB 2017-03-09

SeaSpine® Daytona® Small Stature Spinal System

Applicant SeaSpine Orthopedics Corporation

K-Number K163604

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JGS 2017-03-09

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

Applicant Siemens Healthcare Diagnostics

K-Number K161954

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HRS 2017-03-09

Level One Hand Plating System

Applicant KLS Martin L.P.

K-Number K170124

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MQF 2017-03-09

Transem and EchoGen Embryo Transfer Catheters

Applicant Origio A/S

K-Number K161547

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OWB 2017-03-09

ARTIS pheno

Applicant Siemens Medical Solution USA, Inc.

K-Number K163286

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LBB 2017-03-09

Hoggan Scientific® microFET2™

Applicant Hoggan Scientific, LLC

K-Number K162412

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NBW 2017-03-09

BGM009 Plus Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K170267

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