8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCORDE LIFT
FDA 510(k)
FDA Class 2
·Orthopedic
ET III SA ULTRA WIDE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
LEONARD 10 FR DL CVC, PEEL-APART INTRODUCER KIT
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS INC.·Product code LJS·October 10, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 17, 2013
HOT BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code KGE·July 23, 2011
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