21 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FUSION RESIN CEMENT AND CORE KIT
FDA 510(k)
FDA Class 2
·Dental
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070702·SECRET SKIN, SIZE S, NERO, MICRO-MASSAGING POCK...
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507614·
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113000·LOCATOR R-Tx Abutment for Large Internal Conica...
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481119514·LOCATOR F-Tx Abutment For Large Internal Conica...
XUB EXTERNAL ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·October 30, 2014
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 14, 2017
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 30, 2025
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018
IMPLANT HOLDER FOR SYNFIX(TM)-LR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 22, 2013
NI
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·April 18, 2011
HOYER LIFT
FDA Adverse Event
Other
·APEX HEALTHCARE MFG INC.·Product code FNG·July 2, 2008
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 27, 2020
CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015