21 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultravision Visual Field Clearing System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994185112·CASE 9182053 RESECTION GUID DISTR TEMPLT
Bernafon
FDA UDI
Bernafon AG·05711584077207·AQ CO7 B 105, 2.4G NFM DPB ANBR ACCUQ
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493932511·AVANOS* Single-Shot Epidural Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651932515·HYH,EP TRY,S-SHOT,-,-,10
OBC BONE ANCHORED HEARING SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BUTLER CALCI-FLOR PROPHYLAXIS PASTE
FDA 510(k)
FDA Class 1
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 24, 2024
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 2, 2008
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·June 17, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 22, 2011
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
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
SENSOR MMT-7040MA GS3 5PK US
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·May 27, 2025