17 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00142507010·
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756025034·Needle Counter
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010
FDA 510(k)
FDA Class 2
·Radiology
Skeletal Dynamics Midshaft Humerus Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
TELEGRAPH®
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489507014·
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 14, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 26, 2008
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·September 16, 2011
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·October 15, 2025
SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
FDA Enforcement
Class II
·Ongoing·Chamberlain Technologies LLC·June 25, 2025
SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
FDA Enforcement
Class II
·Ongoing·Chamberlain Technologies LLC·June 25, 2025
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
FDA Enforcement
Class II
·Ongoing·Chamberlain Technologies LLC·June 25, 2025
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
FDA Enforcement
Class II
·Ongoing·Chamberlain Technologies LLC·June 25, 2025
Arrow Three-Lumen CVC
FDA Enforcement
Class II
·Terminated·ARROW INTERNATIONAL Inc.·July 6, 2022
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023