8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RECONDITIONED ASTRA (TM) 8
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HardyDisk AST Omadacycline 30µg (OMC30)
FDA 510(k)
FDA Class 2
·Microbiology
MINI-TIP CULTURETTE
FDA 510(k)
FDA Class 1
·Microbiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 19, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 20, 2010
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·AQUATEC OPERATIONS GMBH·Product code FSA·December 21, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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