15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Safecare Urinary Tract Infection Test
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DATAPRO CLINICAL CHELISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ThinkMed Intermittent Catheter with/without Hydrophilic Coating
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 8, 2025
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 30, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2011
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·July 23, 2013
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 2026
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 29, 2025
DM CONVERTER ¿ TIN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2026
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026