20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHARLOTTE SNAP-OFF SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Neo-Tee T-Piece Resuscitator
FDA UDI
MERCURY ENTERPRISES, INC.·10641043508190·
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018
PHILIPS CT SECURA MV
FDA 510(k)
FDA Class 2
·Radiology
3CC NMT SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 10, 2013
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·September 7, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code NKB·October 8, 2010
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·October 1, 2003
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
FDA Enforcement
Class II
·Terminated·Mercury Enterprises, Inc. dba Mercury Medical·January 20, 2016