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

DRA 2016-09-20

Hansen Medical Magellan Robotic Catheter 9Fr

Applicant Hansen Medical, Inc.

K-Number K160919

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NUJ 2016-09-20

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)

Applicant Sterilmed, Inc.

K-Number K161086

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CDD 2016-09-20

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

Applicant Diazyme Laboratories

K-Number K161721

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DQX 2016-09-20

Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip

Applicant Volcano Corporation

K-Number K161887

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GCJ 2016-09-20

PINPOINT Endoscopic Fluorescence Imaging System

Applicant Novadaq Technologies, Inc.

K-Number K161792

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GYD 2016-09-20

Personal Kinetigraph (PKG) System

Applicant Gkc Manufacturing Pty, Ltd.

K-Number K161717

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KOD 2016-09-20

GentleCath Glide Intermittent Catheter

Applicant Convatec Limited

K-Number K161344

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OOE 2016-09-20

Catalys Precision Laser System

Applicant Optimedica Corporation

K-Number K161455

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LRK 2016-09-20

SomnoDent ALPHA

Applicant Somnomed, Inc.

K-Number K162306

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LLZ 2016-09-19

PixelShine

Applicant Algomedica

K-Number K161625

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DQY 2016-09-19

Super Distal Access (SDA)

Applicant Inneuroco, Inc.

K-Number K161262

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MSX 2016-09-19

AirStrip RPM

Applicant Airstrip Technologies, Inc.

K-Number K160862

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