7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
ACS INDEFLATOR (MODIFICATION)
FDA 510(k)
FDA Class 2
·Cardiovascular
BLOOD-PRESSURE ECG TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
FREESTYLE
FDA Adverse Event
Malfunction
·Product code LFR·June 10, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 7, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 10, 2012
Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016