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

LLZ 2018-12-28

AmCAD-UO

Applicant Amcad Biomed Corporation

K-Number K180867

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JEY 2018-12-28

CranioMaxillofacial Fixation (CMF) System - CMF Visionare

Applicant Visionare, LLC

K-Number K180204

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FRC 2018-12-27

STERRAD VELOCITY Biological Indicator

Applicant Advanced Sterilization Products (Asp)

K-Number K182404

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JDB 2018-12-27

LATITUDE EV Total Elbow Arthroplasty

Applicant Tornier, Inc.

K-Number K182461

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LLZ 2018-12-27

iSchemaView RAPID

Applicant Ischemaview, Inc.

K-Number K182130

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GEX 2018-12-27

Lotus III Multi-Pulsed Er: Yag Laser System

Applicant Laseroptek Co., Ltd.

K-Number K182045

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LLZ 2018-12-27

Quantib ND

Applicant Quantib B.V.

K-Number K182564

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IRP 2018-12-27

Pulse 2.0, Pulse Pro 2.0

Applicant NormaTec Industries, LP

K-Number K183169

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IYN 2018-12-27

minisono

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K182845

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NXO 2018-12-26

LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device

Applicant DiaSorin, Inc.

K-Number K182698

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HRS 2018-12-26

DePuy Synthes Trauma Orthopedic Nail Implants

Applicant DePuy Synthes

K-Number K182783

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LPH 2018-12-26

Delta TT Pro

Applicant Lima Corporate S.P.A.

K-Number K182099

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