7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOMET BIAXIAL TOTAL ELBOW
FDA 510(k)
FDA Class 2
·Orthopedic
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
FDA 510(k)
FDA Class 2
·Cardiovascular
Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BSR·February 22, 2013
ENDOTAK DSP
FDA Adverse Event
Death
·CPI - DEL CARIBE·Product code NVY·February 7, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 5, 2014
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026