13 results
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26ms
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Sources: EU EUDAMED, US FDA
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Precept
FDA UDI
Nuvasive, Inc.·00887517431585·PRECEPT Screw, 10.5x110mm Fixed
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403151309·Snowden-Pencer COTTLE KNIFE GUARD 20CM 8 inches
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575315116·Orthopaedic prosthesis implantation instrument,...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575315505·Orthopaedic prosthesis implantation instrument,...
AIM2
FDA 510(k)
FDA Class 2
·Dental
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45
FDA 510(k)
FDA Class 2
·Orthopedic
NexGen®
FDA UDI
Zimmer, Inc.·00889024199682·
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014
PROXIMATE** LINEAR CUTTER RELOAD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 25, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·December 14, 2012
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 9, 2014