12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ebb Complete Tamponade System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383507707·Gutta Percha Points is used to root canal filin...
SYRINGE 20ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·September 2, 2025
COLS PEEK
FDA 510(k)
FDA Class 2
·Orthopedic
DIGITAL RADIOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE 20ML LL BN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·November 24, 2025
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·June 8, 2013
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 7, 2011
LIGASURE IMPACT LF4318
FDA Adverse Event
Injury
·COVIDIEN LP·Product code GEI·October 15, 2015
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024