10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
SAGI Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114179·KRATZ POLISHER 23GA SIDE (PK/10)
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
FDA 510(k)
FDA Class 2
·Cardiovascular
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
FDA 510(k)
FDA Class 2
·Orthopedic
RELION MICRO BLOOD GLUCOSE SYSTEM
FDA Adverse Event
Injury
·ARKRAY, INC.·Product code NBW·March 12, 2012
GLIDEWELL HT IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 7, 2025
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·November 13, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 3, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 29, 2013
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024