7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFETY PLUS DENTAL INJECTION NEEDLE
FDA 510(k)
FDA Class 1
·Dental
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
UNKNOWN DEPUY DURALOC CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·January 14, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 12, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 3, 2014
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021