7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
DATA-TOPE T3 UPTAKE PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INSIGHT HEAD COIL
FDA 510(k)
FDA Class 2
·Radiology
Dentalis Bio Solution Implants
FDA 510(k)
FDA Class 2
·Dental
SECURESTRAP
FDA Adverse Event
Injury
·ETHICON INC.·Product code GDW·April 21, 2014
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 20, 2007
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·September 26, 2012
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016