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

ODP 2019-03-06

ChoiceSpine Stealth Cervical Spacer System

Applicant Choicespine, LP

K-Number K183397

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GEX 2019-03-06

Joule System

Applicant Sciton, Inc

K-Number K182173

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LPL 2019-03-05

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)

Applicant Eyemed Technologies S.R.L.

K-Number K181656

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HRS 2019-03-05

Stryker SternalPlate System

Applicant Stryker

K-Number K183172

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IYN 2019-03-05

Imagio Ultrasound Imaging System

Applicant Seno Medical Instruments, Inc.

K-Number K182628

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FED 2019-03-05

Embrella Endoscopic Distal Attachment

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K190030

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LGZ 2019-03-05

MAC Medical D-Series Blanket and Solution Warming Cabinets

Applicant Mac Medical, Inc.

K-Number K180842

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NEZ 2019-03-05

Olympus Small Intestinal Capsule Endoscope System

Applicant Olympus Medical Systems Corp.

K-Number K183053

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MAX 2019-03-04

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices

Applicant Spineex, Inc.

K-Number K190193

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HRS 2019-03-04

MLP Special Locking Bone Plate System

Applicant Maxxion Medical, LLC / Baumer SA

K-Number K181843

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ODP 2019-03-04

SCARLET® AC-T Secured Anterior Cervical Cage

Applicant Spineart

K-Number K190322

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OWN 2019-03-04

VS3-IR

Applicant Medtronic

K-Number K183453

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