9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155442·SAGITTAL BLADE - DE SOUTTER PRISMATIC 19 x 100 ...
DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SEALING TAPE, STERILIZATION INDICATOR; STEAM
FDA 510(k)
FDA Class 2
·General Hospital
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 20, 2014
ANTHEM RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
ALBOGRAFT POLYESTER KNITTED VASCULAR GRAFT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR·Product code MAL·November 21, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015