56 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Image1 S CCU, Image1 S 4U Camera Head
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fluid Retention Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM
TAPERLOC COMPLETE RASP/PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304506817·
HEX HANDLE GROOVED TIP SUCKER
FDA UDI
NOVOSCI CORP.·B0662011350000·A hand-held device designed to regulate and dir...
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACUTRAK
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·January 21, 2019
ACUTRAK
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·January 21, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·July 29, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 2, 2013
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2022
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 12, 2011
UNKNOWN COMPREHENSIVE FRACTURE STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSD·January 8, 2015
UNKNOWN COMPREHENSIVE FRACTURE STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSD·January 8, 2015
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
UNKNOWN COMPREHENSIVE FRACTURE STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSD·January 8, 2015
UNKNOWN COMPREHENSIVE FRACTURE STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSD·January 8, 2015
UNKNOWN COMPREHENSIVE FRACTURE STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSD·January 8, 2015
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025