13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Intramedullary Nails
FDA 510(k)
FDA Class 2
·Orthopedic
Disposable Iris Retract
FDA UDI
KATENA PRODUCTS, INC.·00841668114339·FLEXIBLE IRIS RETRACTORS 1 PK of 5
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·April 24, 2019
IMICRYL Impression Materials
FDA 510(k)
FDA Class 2
·Dental
NAJA Gastrointestinal Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 27, 2018
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 14, 2018
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 18, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
ANTIMICROBIAL PICC KIT 1-LUMEN: 4.5 FR X
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code LJS·August 24, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2013
BD ULTRA-FINE INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 17, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025