15 results · 22ms · Sources: EU EUDAMED, 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