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

GEI 2018-09-20

NICO Myriad

Applicant Nico Corporation

K-Number K182340

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NDC 2018-09-20

EndoTool SubQ

Applicant Al Pacheco and Associates

K-Number K180366

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IYN 2018-09-20

LOGIQ P9; LOGIQ P7

Applicant GE Healthcare

K-Number K181783

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NKB 2018-09-20

Chiral Surgical Pedicle Screw System

Applicant Chiral Surgical

K-Number K181995

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LZO 2018-09-20

MicroPort Orthopedics Total Hip Systems MR Labeling

Applicant Microport Orthopedics Inc. (Mpo)

K-Number K173898

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NGX 2018-09-20

Katalyst Mark 1 Muscle Stimulation System Model 2

Applicant Katalyst, Inc.

K-Number K181199

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EZL 2018-09-19

Bard Vertus Foley Catheter

Applicant C.R. Bard, Inc.

K-Number K180781

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MQP 2018-09-19

T2 STRATOSPHERE Expandable Corpectomy System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K181328

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PNL 2018-09-19

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number K180894

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MQP 2018-09-19

FORTIFY Corpectomy Spacers

Applicant Globus Medical, Inc.

K-Number K173982

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LPL 2018-09-19

Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens

Applicant Visco Vision, Inc.

K-Number K181349

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OHT 2018-09-19

Beurer IPL 8500 device/ IPL VelvetSkin Pro

Applicant Home Well Trading, Ltd.

K-Number K181734

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