19 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reusable NIBP Cuff
FDA 510(k)
FDA Class 2
·Cardiovascular
SILVER ANTIMICROBIAL WOUND GEL
FDA 510(k)
FDA Unclassified
·Unknown
APC FLASH-FREE ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
VERCISE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·January 10, 2022
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·January 2, 2025
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·February 18, 2025
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·September 12, 2024
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 14, 2024
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013
THINLINE II STEROX
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
*
FDA Adverse Event
Malfunction
·BIOMET·Product code JWH·September 30, 2014
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·May 17, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 18, 2019
OPTILITE SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·June 5, 2020
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 12, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 18, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·November 4, 2022
OPTILITE SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 13, 2020
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed 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