9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CAMPY BROTH
FDA 510(k)
FDA Class 1
·Microbiology
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028801070·3 User Oil Free Compressor | 1.5 HP w/Dryer 13 ...
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
FDA 510(k)
FDA Class 2
·Microbiology
Blue Sky Bio Aligner
FDA 510(k)
FDA Class 2
·Dental
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014
PRESICE ICEROD PROSTATE KIT
FDA Adverse Event
Malfunction
·GALIL MEDICAL LTD.·Product code GEH·June 17, 2010
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·December 19, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020