4 results
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8ms
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Sources: EU EUDAMED, US FDA
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
FDA Enforcement
Class II
·Ongoing·Alcon Research, LLC·July 20, 2022
Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
FDA Enforcement
Class II
·Terminated·Ecolab Inc·October 31, 2018
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021