8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Identity Revision Humeral Stems
FDA 510(k)
FDA Class 2
·Orthopedic
Ambu Duodeno System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
9MM/125 DEG TI CANN TFNA 235MM/RIGHT-STERILE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·December 11, 2017
CARESCAPE B850
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·November 5, 2014
ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·September 8, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 29, 2013
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·June 24, 2026