13 results · 21ms · Sources: EU EUDAMED, 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