12 results
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19ms
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Sources: EU EUDAMED, US FDA
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·January 15, 2019
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARESIDE CHOLINESTERASE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DRF·March 15, 2023
Frederick Miller
FDA UDI
COOK INCORPORATED·00827002069503·Frederick Miller Feeding Tube
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 26, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 16, 2011
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026