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

JWH 2017-01-19

Anatomic Total Knee System

Applicant Amplitude

K-Number K161414

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DZE 2017-01-19

GMI Frontier Dental Implant System

Applicant Ilerimplant S.L

K-Number K161593

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OMP 2017-01-19

Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set

Applicant Cardinalhealth

K-Number K161418

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OLV 2017-01-19

Polysmith Sleep System, Model NTI7593

Applicant Neurotronics, Inc.

K-Number K161650

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EGS 2017-01-19

Titan 3 Low Speed Angle Attachments

Applicant Dentalez, Inc.

K-Number K162397

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PQX 2017-01-19

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

Applicant Certa Dose, Inc.

K-Number K160589

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JOW 2017-01-19

Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves

Applicant Covidien

K-Number K163620

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LOX 2017-01-19

NC Gallant PTCA Catheter

Applicant Medinol, Ltd.

K-Number K162434

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IYE 2017-01-19

TrueBeam-TrueBeam STx-Edge

Applicant Varian Medical Systems, Inc.

K-Number K162472

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NEZ 2017-01-19

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

Applicant Olympus Medical Systems Corp.

K-Number K163069

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MNS 2017-01-19

Juno VPAP ST-A

Applicant Resmed, Ltd.

K-Number K161492

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FMI 2017-01-19

meso-relle (AAL34, AAL36, AM30G)

Applicant Biotekne Srl

K-Number K161255

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