17 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Adapter
FDA UDI
I.T.S. GmbH·09120069812800·Adapter, Cannulated Femur Nail
INFX-8000V WITH
FDA 510(k)
FDA Class 2
·Radiology
S-TEST CREATININE (CRE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 24, 2024
N600X PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO·Product code DQA·June 13, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
PUMP MMT-712RNAP PRDGM INS PL EN US RC
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·September 26, 2008
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·September 30, 2024
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·October 7, 2024
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·October 21, 2024
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·April 24, 2019
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 19, 2021
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 19, 2021
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 28, 2022
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 21, 2024
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 2, 2013